CLASS I ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

A M S, Aligned Medical Solutions, Dr. Lewin Pack recalled

Windstone Medical Packaging is recalling A M S, Aligned Medical Solutions, Dr. Lewin Pack, Pack Number AMS7200D, surgical, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

Quantity recalled45 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2622-2026
FDA event ID: 99189
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class I
Status: Ongoing
Recall initiated: 21 May 2026
FDA classified: 1 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Surgical Instruments

Timeline

21 May 2026	Recall initiated by company
1 Jul 2026	Classified by FDA	+41 days
8 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit

Where it was distributed

US Nationwide distribution in the states of PA, GA, CA, WA.

Nationwide California Georgia Pennsylvania Washington

Questions about this recall

Why was it recalled?

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Which lots are affected?

UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

Where was it sold?

US Nationwide distribution in the states of PA, GA, CA, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99189

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026	CLASS I	A M S, Aligned Medical Solutions, Thyroid Fna Pack-RX recalled	Windstone Medical Packaging	Sterility	Nationwide
8 Jul 2026	CLASS I	A M S, Aligned Medical Solutions, Dsaek Pack-RX recalled	Windstone Medical Packaging	Sterility	Nationwide
8 Jul 2026	CLASS I	A M S, Aligned Medical Solutions, Preop Kit-NS recalled	Windstone Medical Packaging	Sterility	Nationwide

More recalls from Windstone Medical Packaging

All 337

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Sterility	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide