GEM NEUROTUBE — Class II medical device recall Z-1461-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-05-03, distributed nationwide. The product is brittle and potentially crumbling upon handling or when being removed from its package.
| Recall number | Z-1461-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-03-27 |
| Classified | 2023-04-25 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CN, DE, FR, GR, NL, NO, SE |
| Quantity | 169 units |
| Lot numbers | 19012112 |
| Expiration dates | 2023-12-31 |
Product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Reason for recall
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.