BAUSCH + LOMB CATARACT PACK — Class II medical device recall Z-0161-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-11-09, distributed nationwide. Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in
| Recall number | Z-0161-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-09-30 |
| Classified | 2022-11-01 |
| Reported by FDA | 2022-11-09 |
| Distributed | Nationwide (US) |
| Quantity | 708 kits |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10195327108168 |
| Lot numbers | 22DBL466 |
| Model numbers | VAL001CPMEA |
Product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Reason for recall
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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-0161-2023. 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.