Recall Ledger

A M S recall (Windstone Medical Packaging, Inc.)

Medical deviceClass IOngoing

Summary: Windstone Medical Packaging, Inc. is recalling A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit. Reason: 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.

What is being recalled

A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

Why

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.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

US Nationwide distribution in the states of PA, GA, CA, WA. (states named: California, Georgia, Pennsylvania, Washington)

How to tell if yours is 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.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2620-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedMay 21, 2026
ReportedJuly 8, 2026
CompanyWindstone Medical Packaging, Inc.
Company locationBillings, MT, United States
Initiated byVoluntary: Firm initiated
Quantity200 units

More recalls from Windstone Medical Packaging, Inc. · all medical device recalls · recalls from May 2026

Official FDA record