Aligned Medical Solutions Hand Pack — Class II medical device recall Z-1621-2023
Ongoing recall by Windstone Medical Packaging, Inc., reported 2023-05-31. Light handle covers may separate from the light handle (detach and fall off) during use, this could result in
| Recall number | Z-1621-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2023-04-24 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Quantity | 60 kits |
| Reason classes | sterility, device malfunction |
| Lot numbers | 188843 |
| Model numbers | AMS4601E |
Product
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
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-1621-2023. 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.