FDA Device recall Z-1620-2023
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- FDA Device
- Class II
- ongoing
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO by Windstone Medical Packaging, 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-1620-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-24 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Windstone Medical Packaging |
| Distribution | MA |
Product
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
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 | Lot #s 187154 and 189008, UDI: B098AMS6539E0 |
|---|
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-1620-2023%22
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