Covidien Auto Suture" Structural Balloon Trocar — Class II medical device recall Z-1465-2024
Ongoing recall by Covidien, LP, reported 2024-04-10, distributed nationwide. The potential for trocar seal disengagement when using mesh products incorrectly with the device.
| Recall number | Z-1465-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2024-02-28 |
| Classified | 2024-04-03 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, AW, BE, BG, BR, CA, CH, CO, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IT, JO, JP, KE, KR, LU, MT, MX, MY, NG, NL, NO, NZ, OM, PL, PT, RO, SA, SE, SG, SI, SK, TH, TR, TT, TW, VN, ZA |
| Quantity | 124,863 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10884521081086, 20884521081083 |
| Serial numbers | P0B1097Y, P0L1408, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1470, P1A1485, P1A1486, P1B1294, P1B1449, P1C0441, P1C1565, P1C1566, P1C1568, P1C1674, P1C1675, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1380, P1D1509 and 92 more |
Product
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Reason for recall
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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-1465-2024. 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.