STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0 — Class II medical device recall Z-1053-2022
Ongoing recall by Ethicon, Inc., reported 2022-05-18. Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
| Recall number | Z-1053-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2022-03-24 |
| Classified | 2022-05-10 |
| Reported by FDA | 2022-05-18 |
| Countries outside the US | CN |
| Quantity | 2,808 |
| UPC / GTIN / UDI-DI | 10705031228047, 10705031228054 |
| Lot numbers | AAHM529, AAHQ049 |
Product
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Reason for recall
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
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-1053-2022. 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.