PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm — Class II medical device recall Z-2533-2018
Terminated recall by Ethicon, Inc., reported 2018-08-01. Products do not meet a tensile strength specification
| Recall number | Z-2533-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2018-06-08 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-09-25 |
| Countries outside the US | JP |
| Quantity | 756 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10705031203945 |
| Lot numbers | MCZ162 |
Product
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
Reason for recall
Products do not meet a tensile strength specification
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-2533-2018. 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.