PDS Plus Antibacterial — Class II medical device recall Z-2616-2023
Ongoing recall by ETHICON, LLC, reported 2023-09-27, distributed nationwide. Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from th
| Recall number | Z-2616-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ETHICON, LLC, Guaynabo, PR, United States |
| Recall initiated | 2023-08-10 |
| Classified | 2023-09-20 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 868,363 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031048447, 10705031048546, 10705031048553, 10705031122574, 10705031123540, 10705031123564, 10705031123588, 10705031123595, 10705031123786, 10705031123854, 10705031123861, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124769, 10705031124875, 10705031124899 and 4 more |
Product
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16
Reason for recall
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
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-2616-2023. 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.