โš  RecallRadar๐Ÿ“ท ScanGuidesOfficial U.S. recall notices, restated plainly

Recalls in Delaware

Official recalls distributed in Delaware: 87 listing Delaware by name, plus 4071 nationwide recalls. Vehicle (NHTSA) and consumer product (CPSC) recalls are not listed by state; see all recalls.

Distributed in Delaware (87)

Bard Access Systems, Inc.: Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;
Medical DevicesFDA (device) ยท 2026-09-23 ยท Class I
Bard Access Systems, Inc.: DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short
Medical DevicesFDA (device) ยท 2026-09-23 ยท Class I
Lidl US TRADING: ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with
FoodFDA (food) ยท 2026-09-02 ยท Class II
Lidl US TRADING: ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic car
FoodFDA (food) ยท 2026-09-02 ยท Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315
FoodFDA (food) ยท 2026-09-02 ยท Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate
FoodFDA (food) ยท 2026-09-02 ยท Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanat
FoodFDA (food) ยท 2026-09-02 ยท Class II
SDI Limited: Dentsply Sirona Capsule Mixer Model No. 5546068
Medical DevicesFDA (device) ยท 2026-08-26 ยท Class II
Prospector Popcorn, LLC: Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz.
FoodFDA (food) ยท 2026-08-26 ยท Class II
Prospector Popcorn, LLC: Prospector Popcorn Maple Walnut Ice Cream Gourmet Popcorn 3.5 oz.
FoodFDA (food) ยท 2026-08-26 ยท Class III
Prospector Popcorn, LLC: Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
FoodFDA (food) ยท 2026-08-26 ยท Class III
Prospector Popcorn, LLC: Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz
FoodFDA (food) ยท 2026-08-26 ยท Class III
Lidl US TRADING: VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZ
FoodFDA (food) ยท 2026-08-26 ยท Class I
Galliker Dairy Co, Inc.: DQ Chocolate Reduced Fat Ice Cream Mix, 5 GAL (18.9L). Keep refrigerated.
FoodFDA (food) ยท 2026-08-05 ยท Class II
Nutricia North America: functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 0
FoodFDA (food) ยท 2026-07-22 ยท Class II
Nutricia North America: functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 O
FoodFDA (food) ยท 2026-07-22 ยท Class II
Smith & Nephew, Inc.: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
Intuitive Surgical, Inc.: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Prefa
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
Wawa Beverage Company: Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
FoodFDA (food) ยท 2026-06-03 ยท Class I
Wawa Beverage Company: Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
FoodFDA (food) ยท 2026-06-03 ยท Class I
Wawa Beverage Company: Wawa Diet Lemonade Pint (16oz), Plastic bottle
FoodFDA (food) ยท 2026-06-03 ยท Class I
Wawa Beverage Company: Wawa Fruit Punch Pint (16oz), Plastic bottle
FoodFDA (food) ยท 2026-06-03 ยท Class I
Llorens Pharmaceuticals International Division, Inc.: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bottle, 47 SERVING PER B
FoodFDA (food) ยท 2026-05-27 ยท Class II
Raja Foods and Vegetables Inc.: Swad Orange Flavored Masala Candy
FoodFDA (food) ยท 2026-05-20 ยท Class II
Raja Foods and Vegetables Inc.: Swad Mango Flavored Masala Candy
FoodFDA (food) ยท 2026-05-20 ยท Class II
Intuitive Surgical, Inc.: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Medical DevicesFDA (device) ยท 2026-05-13 ยท Class I
PURE PALM C/O DVD: Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC:
FoodFDA (food) ยท 2026-04-22 ยท Class II
Stryker Sustainability Solutions: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability So
Medical DevicesFDA (device) ยท 2026-04-15 ยท Class II
TG FOODS INC: Divided Sunset Multi Collagen Peptides, 8 Ounce, Stand-up Pouch, UPC Code: 8 50005 60689 5
FoodFDA (food) ยท 2026-04-08 ยท Class II
JFE FRANCHISING INC: " Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable 5.7 oz
FoodFDA (food) ยท 2026-04-08 ยท Class II
JFE FRANCHISING INC: " Dumpling Party Tray (20pcs) Vegetable 13 oz 011110661173 " Dumpling Party Tray (40pcs) Vegetable 26 oz
FoodFDA (food) ยท 2026-04-08 ยท Class II
Super World Trading Inc.: MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate,
FoodFDA (food) ยท 2026-04-08 ยท Class III
Super World Trading Inc.: MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesul
FoodFDA (food) ยท 2026-04-08 ยท Class III
Super World Trading Inc.: MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 1
FoodFDA (food) ยท 2026-04-08 ยท Class III
Ajinomoto Foods North America Inc.: Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UP
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. Retail bag UPC 00521482. Product packaging is flexible bags in a maste
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in a
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per b
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box.
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UP
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Product packaging is flexible bags in a master
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is
FoodFDA (food) ยท 2026-04-01 ยท Class II
Ajinomoto Foods North America Inc.: Item 6430153 Ajinomoto Vegetable Gyoza Dumplings. Net wt. 24.7oz. per bag. Retail box UPC: 071757010109. Product packaging is flexible bags
FoodFDA (food) ยท 2026-04-01 ยท Class II
Savannah Bee Company Inc.: SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD
FoodFDA (food) ยท 2026-04-01 ยท Class II
Lidl US TRADING: Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arli
FoodFDA (food) ยท 2026-04-01 ยท Class II
Wawa Beverage Company: Wawa Reduced Fat Milk 2% 16 oz (Pint)
FoodFDA (food) ยท 2026-03-25 ยท Class II
Wawa Beverage Company: Wawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated
FoodFDA (food) ยท 2026-03-25 ยท Class II
Wawa Beverage Company: Wawa Cookies & Cream Milk 16 oz (Pint), Plastic bottle Store Refrigerated
FoodFDA (food) ยท 2026-03-25 ยท Class II
Wawa Beverage Company: Wawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated
FoodFDA (food) ยท 2026-03-25 ยท Class II
Palmetto Gourmet Foods Inc.: VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains:
FoodFDA (food) ยท 2026-03-18 ยท Class II
Palmetto Gourmet Foods Inc.: VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Palm oil***" Contains: Whea
FoodFDA (food) ยท 2026-03-18 ยท Class II
Rich Products Corp: GLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED
FoodFDA (food) ยท 2026-02-11 ยท Class II
QUTEN RESEARCH INSTITIUTE LLC: Qunol, Extra Strength Turmeric Capsule, 1000mg ,HDPE bottle with cap, BIO7771 120 count bottle, BIO7772 120 count bottle ,BIO8281 60 count b
FoodFDA (food) ยท 2026-02-04 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion system; Software Version Number: R3.1;
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
Intuitive Surgical, Inc.: Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Descrip
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
Beckman Coulter Ireland, Inc.: The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipopro
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
Ambriola Co., Inc., The: Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Pinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Boar's Head Pecorino Romano Grated, 5-pound plastic bag (unit)
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Ambriola Piccante grated Pecorino Romano, 5 and 10-pound plastic bags (units)
FoodFDA (food) ยท 2026-01-14 ยท Class I
Ambriola Co., Inc., The: Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
FoodFDA (food) ยท 2026-01-14 ยท Class I
South Asian Food Inc.: Bengal King Jhal Chanachur food treats 12.34oz (350gm)
FoodFDA (food) ยท 2026-01-14 ยท Class I
Wegmans Food Markets, Inc.: Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in cylindrical clear plastic tubs with lid
FoodFDA (food) ยท 2025-12-31 ยท Class I
Instrumentation Laboratory: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class III
DICOM Grid, Inc.: Intelerad InteleShare software, with ProViewer component
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class II
Medtronic MiniMed, Inc.: InPen App, Model/CFN Number: MMT-8061 (Android Users)
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class II
Lexunder Inc: Food to Live brand ORGANIC MORINGA LEAF POWDER, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 2 lb., 4 lb., 8 lb., 16 lb
FoodFDA (food) ยท 2025-12-24 ยท Class I
Lexunder Inc: Food to Live brand ORGANIC SUPERGREENS POWDER MIX, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 1.5 lb., 3 lb., 6 lb.,
FoodFDA (food) ยท 2025-12-24 ยท Class I
Costco Wholesale Corporation: Costco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it
FoodFDA (food) ยท 2025-12-10 ยท Class II
Costco Wholesale Corporation: Costco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The n
FoodFDA (food) ยท 2025-12-10 ยท Class II
Nutrition for Longevity: Loaded Veggie Grain Bowl; NET WT. 10/90 OZ (309g) NO UPC Identifying N4L code: V3FR
FoodFDA (food) ยท 2025-12-10 ยท Class II
Merit Medical Systems, Inc.: PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/
Medical DevicesFDA (device) ยท 2025-11-26 ยท Class II
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Medical DevicesFDA (device) ยท 2025-11-26 ยท Class III
FreshRealm: Loaded Veggie Grain Bowl; Net Wt. 10.90 Oz (309g) GTIN code: 00818905028162
FoodFDA (food) ยท 2025-11-19 ยท Class II
Tandem Diabetes Care, Inc.: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del
Medical DevicesFDA (device) ยท 2025-11-12 ยท Class I
Tai Foong USA Inc: Fusia Asian Inspirations brand Veggie Spring Rolls. Net weight: 10 oz (283.5 g).) retail package identified by UPC 4099100222258. Type of
FoodFDA (food) ยท 2025-11-05 ยท Class I
Sprouts Farmers Market: Sprouts Smoked Mozzarella Pasta Salad, RTE Pasta Salad, Refrigerated, 5 day shelf life, packaged into plastic containers at Deli counter and
FoodFDA (food) ยท 2025-10-29 ยท Class I
Cook Medical Incorporated: Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W
Medical DevicesFDA (device) ยท 2025-10-22 ยท Class I
Wawa Beverage Company: Wawa HVD (Whole) Milk , 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191014403
FoodFDA (food) ยท 2025-10-22 ยท Class II
Wawa Beverage Company: Wawa Strawberry Milk, Lowfat Milk, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191015134
FoodFDA (food) ยท 2025-10-22 ยท Class II
Wawa Beverage Company: Wawa Strawberry Lemonade, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 007626191018982
FoodFDA (food) ยท 2025-10-22 ยท Class II

Nationwide (4071)

Kayem Foods Inc. Recalls Meat and Poultry Products Due to Possible Temperature Abuse
Meat, Poultry & EggUSDA FSIS ยท 2026-10-17 ยท High - Class I
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Versi
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Versi
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Sof
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Sof
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A7
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A701
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A7
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: N
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: N
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue Model/Catalog Number: ASP-564013 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Versio
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applica
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applica
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Custom Interventional Pain Management, LLC: Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Illumina, Inc.: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
Draeger, Inc.: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
HeartSine Technologies Ltd: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class III
Alere San Diego, Inc.: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fis
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Pa
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-10
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Bard Peripheral Vascular Inc: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with softw
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Volcano Corp: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 530 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 550 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 760 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 780 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Desc
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Produc
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Des
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LM
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Mode
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KI
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Heraeus Medical GmbH (Dental Division): PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cem
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II

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