CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report

Ams Aligned Medical Solutions medical convenience kits recalled

Windstone Medical Packaging is recalling Ams Aligned Medical Solutions medical convenience kits labeled as: ENT Pack, Pack Number, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.

Quantity recalled919 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-2800-2026
FDA event ID: 99323
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2026
FDA classified: 24 Jul 2026
Reported: 5 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Jun 2026	Recall initiated by company
24 Jul 2026	Classified by FDA	+46 days
5 Aug 2026	Published in enforcement report	+12 days

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

Reason for recall

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

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

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.

Nationwide Arizona California Connecticut Georgia Illinois Massachusetts Maryland New York Ohio Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, 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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 99323

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

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