FDA Device recall Z-1476-2023
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape…
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape… by Steris, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1476-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-17 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Steris |
| Distribution | US |
Product
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
Reason
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
Identifiers
| code_info | GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2023%22
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