BAUSCH+LOMB — Class I medical device recall Z-2254-2024
Ongoing recall by Synergetics Inc, reported 2024-07-17, distributed nationwide. Sterilization certificates could not be validated by the supplier
| Recall number | Z-2254-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synergetics Inc, O Fallon, MO, United States |
| Recall initiated | 2024-06-12 |
| Classified | 2024-07-11 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| UPC / GTIN / UDI-DI | 20841305107612 |
| Lot numbers | P62764970R |
| Model numbers | 18069W |
Product
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Reason for recall
Sterilization certificates could not be validated by the supplier
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-2254-2024. 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.