⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Medline Industries, LP: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROB

Medical DevicesSource: FDA (device) · Date: 2025-11-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF DYNJ907910B; 20) GP-ROBOTIC PACK-LF, REF PHS504647004G.
Reason / hazard
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-09-30
Code info
REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 23LBV707; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD429; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD498; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24DBK836; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24HBE577; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23HBO463; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23JBF467; REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 24ABP835; REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case), Lot Numbers: 24CBK422; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23GBT512; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23HBI619; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23LBN095; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24BBR322; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBA027; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBT103; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24EBG556; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23GBO806; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23HBJ772; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23EDB052; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB708; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB759; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23DBJ363; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23EBU559; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23HBL687; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23JBD927; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 23LBG811; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 24BBQ970; REF DYNJ64234C: UDI/DI 10195327486921 (each) 40195327486922 (case), Lot Numbers: 23JMA672; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23EMH332; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23HMB194; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBJ145; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBK217; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23FBS005; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23GBP632; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23IBP551; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23JBH964; REF DYNJ86154: UDI/DI 10195327598112 (each) 40195327598113 (case), Lot Numbers: 24CBA421; REF DYNJ900296K: UDI/DI 10195327554088 (each) 40195327554089 (case), Lot Numbers: 23LBG402; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBF280; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBO223; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24ABV771; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24CBC856; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24ABS777; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24BBB142; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24CBI705; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24EBN319; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC169; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC442; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMG251; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KMC642; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KME178; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23LMC669; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24ABT614; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24DBM183; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24EBJ705; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24ABC736; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24DBD770; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24EBH118; REF PHS504647004G: UDI/DI 10195327454142 (each) 40195327454143 (case), Lot Numbers: 23HDB026.
Product quantity
2844 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
97846
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