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Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/

Medical DevicesSource: FDA (device) · Date: 2026-05-06

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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 medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
Reason / hazard
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution.
Recall initiated
2026-03-19
Code info
Medline Kit Number/SKU DYNJ32854B: UDI/DI each 10198459413414, UDI/DI case 40198459413415, Lot Number : 25GBU656; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25GMD214; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25FMC376; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25DMJ030; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25BME902; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25AMJ032; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24IMH612; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24EME486; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24DMD315; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 26BMD607; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 25JMD196.
Product quantity
208 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98664
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