FDA Device recall Z-2018-2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SK…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SK… by Medline Industries, citing 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-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2018-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Medline Kit Number/SKU DYNJ32854B: UDI/DI each 10198459413414, UDI/DI case 40198459413415, Lot Number : 25GBU656; Med…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 c |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2018-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.