POLYSIN — Class II medical device recall Z-1534-2024
Ongoing recall by SURGICAL SPECIALTIES, reported 2024-04-24, distributed in AZ, CA, IL, MA, MD, MN, NJ, PA…. Complaints have been received with allegations of Incorrect Needle Curvature.
| Recall number | Z-1534-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SURGICAL SPECIALTIES, Westwood, MA, United States |
| Recall initiated | 2024-03-26 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | AZ, CA, IL, MA, MD, MN, NJ, PA, TX |
| Countries outside the US | NZ |
| Quantity | 2,459 units |
| UPC / GTIN / UDI-DI | 00848782015115 |
| Lot numbers | C318TXK, C725TAC, C902CCF, D215GJN, D413FLD, D503OCB, D524ZOU, DA26LQG |
| Model numbers | G503N |
Product
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Reason for recall
Complaints have been received with allegations of Incorrect Needle Curvature.
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-1534-2024. 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.