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

A M S, Aligned Medical Solutions, Dsaek Pack-RX recalled

Windstone Medical Packaging is recalling A M S, Aligned Medical Solutions, Dsaek Pack-RX, Pack Number AMS12394B, 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 recalled1080 kits

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-2619-2026
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, DSAEK Pack-RX, Pack Number AMS12394B, 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

Is A M S, Aligned Medical Solutions, Dsaek Pack-RX, Pack Number AMS12394B, surgical recalled?

Yes. Windstone Medical Packaging recalled A M S, Aligned Medical Solutions, Dsaek Pack-RX, Pack Number AMS12394B, surgical on 21 May 2026. The recall is Class I and its status is Ongoing. Recall number Z-2619-2026.

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

More recalls from Windstone Medical Packaging

All 336

Reported	Class	Recall	Company	Reason	Where
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
5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Sterility	Nationwide

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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide