FDA Device recall Z-2021-2026
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc 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-2021-2026 |
| 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 and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
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 AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline…Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942 |
|---|
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-2021-2026%22
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