Steris Lighting and Visualization Systems — Class II medical device recall Z-1475-2023
Ongoing recall by Steris Corporation, reported 2023-05-10, distributed nationwide. Light handle covers may separate from the light handle (detach and fall off) during use, this could result in
| Recall number | Z-1475-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2023-03-17 |
| Classified | 2023-04-28 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 1,358,520 covers |
| Reason classes | sterility, device malfunction |
| UPC / GTIN / UDI-DI | 00724995150136 |
| Lot numbers | 9604187, 9604187A, 9604188, 9604188A, 9604189, 9604189A, 9604190, 9604190A, 9604191, 9604191A, 9799082, 9799082A, 9799083, 9799083A, 9799084, 9799084A, 9799085, 9799085A, 9799086, 9799086A, 9799087, 9799087A, 9799088, 9799088A, 9799089, 9799089A, 9799090, 9799090A, 9799091, 9799091A, 9799092, 9799092A, 9799093, 9799093A, 9799094, 9799094A, 9799095, 9799095A, 9799096, 9799096A and 24 more |
| Model numbers | LB53 |
Product
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Reason for recall
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
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-1475-2023. 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.