PDS¿ Plus Antibacterial — Class II medical device recall Z-1571-2023
Ongoing recall by Ethicon, Inc., reported 2023-05-17. Suture breakage during intra-operative use could result in poor performance of the impacted product because th
| Recall number | Z-1571-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Raritan, NJ, United States |
| Recall initiated | 2023-03-31 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Countries outside the US | GB, IE, TR |
| Quantity | 1,656 eaches |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10705031124691, 30705031124695 |
Product
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Reason for recall
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
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-1571-2023. 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.