PDS II SUTURE 18" — Class II medical device recall Z-1136-2019
Terminated recall by Ethicon, Inc., reported 2019-04-24, distributed nationwide. VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton a
| Recall number | Z-1136-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2019-03-12 |
| Classified | 2019-04-12 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, IL, JP, SG |
| Quantity | 550,681 eaches |
| Reason classes | labeling |
| Lot numbers | MGM110 |
Product
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
Reason for recall
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
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-1136-2019. 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.