Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK… — Class II medical device recall Z-1182-2023
Ongoing recall by Covidien, LP, reported 2023-03-08, distributed nationwide. Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases
| Recall number | Z-1182-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2022-12-02 |
| Classified | 2023-02-25 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 9,606 |
| Reason classes | sterility |
| Lot numbers | A1K0283Y, A1K0289Y, A1K0291Y, A2E0454Y, US1638, US1756 |
| Model numbers | A1K0283Y, A1K0289Y, A1K0291Y, A2E0454Y, US1638, US1756 |
Product
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Reason for recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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-1182-2023. 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.