FDA Device recall Z-2030-2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80…
- 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. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80… 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-2030-2026 |
| 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. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
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 DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 22GBV101; Med…Medline Kit Number/SKU DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 22GBV101; Medline Kit Number/SKU DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 24IBG473; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25EBT656; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25DBN421; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25CBN640; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBL172; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBD651; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25ABA455; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI c |
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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-2030-2026%22
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