PDS II — Class II medical device recall Z-2146-2024
Ongoing recall by Ethicon, Inc., reported 2024-06-26, distributed nationwide. Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromis
| Recall number | Z-2146-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Raritan, NJ, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-06-14 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 56,952 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10705031026216, 10705031060166, 10705031060289, 10705031060395, 10705031060517 |
| Lot numbers | VCP196H |
Product
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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-2146-2024. 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.