Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K — Class II medical device recall Z-1296-2020
Terminated recall by Covidien LLC, reported 2020-02-26, distributed nationwide. There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific pr
| Recall number | Z-1296-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2019-12-18 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2022-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 139,938 units |
| Reason classes | sterility, packaging |
| Lot numbers | D7H0946X |
| Model numbers | SL654 |
| Expiration dates | 2022-08-31 |
Product
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Reason for recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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-1296-2020. 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.