Use cautionMedical device recall · FDA · Published April 24, 2023
Windstone Medical: Aligned Hand Pack Light Handle May Detach During Use
Windstone Medical recalls Aligned Hand Pack REF AmS460: P2 Cover Light Handle Blue STE may detach during use, risking procedure delays or patient injury. Affected units contain Lot 188843.
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
Take action
Contact the company
📍Recalling firmWindstone Medical Packaging, Inc.1602 4th Ave N · Billings, MT 59101-1521
“Windstone Medical: Aligned Hand Pack Light Handle May Detach During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58510-windstone-medical-aligned-hand-pack-light-handle-may-detach-during. Based on FDA recall #Z-1621-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2023%22&limit=1).
The FDA announced on April 24, 2023, that Windstone Medical Packaging, Inc. voluntarily recalled Aligned Medical Solutions Hand Packs containing P 2 Cover Light Handle Blue STE due to a potential injury hazard. The agency stated the recall is ongoing.
How to tell if you have it
Brand: Windstone Medical
Product: Aligned Medical Solutions Hand Pack
REF: AmS4601E
Lot: 188843
UDI: B098AMS4601E0
The hazard
According to the FDA, light handle covers may separate from the light handle during use. This detachment could result in a procedure delay and/or impact the sterile field, which could result in an injury to the patient.
Context
GovInfoNow's records show Windstone Medical Packaging, Inc. has 14 other recalls on record since October 24, 2017. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (December 4, 2025), Merit Medical Allwell Angioplasty Pack Recall (December 4, 2025), and Merit Medical Custom Manifold Kit Recall (December 4, 2025).
How to tell if you have this one
Check for the reference number AmS4601E on the packaging. The product contains Lot 188843 and UDI: B098AMS4601E0. This recall applies to the specific hand pack model used in medical procedures.
Brand
Windstone Medical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US: MA OUS: None
Recall number
Product, codes & lots
Quantity
Z-1619-2023
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO; Lot #s 187143 and 188654; UDI: B098AMS4599C0
30 kits
Z-1620-2023
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO; Lot #s 187154 and 189008, UDI: B098AMS6539E0
90 kits
Z-1621-2023
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO; Lot 188843; UDI: B098AMS4601E0
60 kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number AmS4601E and lot number 188843 on the packaging.
Where it went and when
Where it was distributed
Distributed in Massachusetts.
Listed by the agency
Not listed
FDA distribution: “US: MA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1621-2023 (April 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1621-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.