CLASS I ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
A M S, Aligned Medical Solutions, Thyroid Fna Pack-RX recalled
Windstone Medical Packaging is recalling A M S, Aligned Medical Solutions, Thyroid Fna Pack-RX, Pack Number AMS17729, 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
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-2620-2026
- 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, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Where it was distributed
US Nationwide distribution in the states of PA, GA, CA, WA.
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 99189This product is part of a recall event; the main page for the event is A M S, Aligned Medical Solutions, Dr. Lewin Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | A M S, Aligned Medical Solutions, Dr. Lewin Pack recalled | Windstone Medical Packaging | Sterility | Nationwide | |
| CLASS I | A M S, Aligned Medical Solutions, Dsaek Pack-RX recalled | Windstone Medical Packaging | Sterility | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |