CODMAN Disposable Perforator — Class I medical device recall Z-1716-2025
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-05-14, distributed nationwide. Inadequate weld that can potentially cause the product to disassemble.
| Recall number | Z-1716-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-04-11 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BR, BS, CA, CH, CL, CO, CY, CZ, DE, DO, EC, ES, FR, GB, GH, GR, HK, IE, IL, IN, IT, JO, JP, KE, KR, LB, LK, LT, MA, MY, NL, NP, NZ, PK, PL, PT, QA, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, ZA |
| Quantity | 170,510 units |
| UPC / GTIN / UDI-DI | 10381780513599 |
| Lot numbers | 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448 and 460 more |
| Model numbers | 261221 |
Product
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Reason for recall
Inadequate weld that can potentially cause the product to disassemble.
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-1716-2025. 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.