PDS Plus Antibacterial — Class II medical device recall Z-1339-2018
Terminated recall by Ethicon, Inc., reported 2018-04-18, distributed nationwide. Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an exp
| Recall number | Z-1339-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2018-01-10 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CO, IN |
| Quantity | 72 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10705031048584 |
| Lot numbers | LL6590 |
Product
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Reason for recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
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-1339-2018. 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.