Box as labeled: Regard — Class II medical device recall Z-0985-2024
Ongoing recall by CooperSurgical, Inc., reported 2024-02-14, distributed nationwide. Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
| Recall number | Z-0985-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2023-08-29 |
| Classified | 2024-02-05 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 60888937027053 |
| Lot numbers | 326728 |
| Model numbers | 733776 |
Product
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
Reason for recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
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-0985-2024. 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.