FDA recall, , High risk
Aligned Medical Solutions Surgical Convenience Kits
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.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc. of Billings, Montana, began a recall on May 21, 2026, of surgical convenience kits that 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.
The kits include A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D; Thyroid FNA Pack-RX, Pack Number AMS17729; Preop Kit-NS, Pack Number AMS18227; and DSAEK Pack-RX, Pack Number AMS12394B. The FDA added the recall to its Enforcement Report on July 1, 2026, and it was listed in the weekly enforcement report on July 8, 2026.
Distribution was US Nationwide distribution in the states of PA, GA, CA, WA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
4 products
Affected if its lot code is listed.
A M S, Aligned Medical Solutions, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
- Lot code
- 237663
- 237901
- 237957
- 238041
- 238084
- 238085
- 238146
- 238197
- 238589
- 239157
- 239216
- 239286
- 239337
- 239386
- 239943
- 240269
- 240633
- 240705
- 240903
- 240904
- 241034
- 241223
- 241224
- 241313
A M S, Aligned Medical Solutions, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- Lot code
- 237663
- 237901
- 237957
- 238041
- 238084
- 238085
- 238146
- 238197
- 238589
- 239157
- 239216
- 239286
- 239337
- 239386
- 239943
- 240269
- 240633
- 240705
- 240903
- 240904
- 241034
- 241223
- 241224
- 241313
A M S, Aligned Medical Solutions, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
- Lot code
- 237663
- 237901
- 237957
- 238041
- 238084
- 238085
- 238146
- 238197
- 238589
- 239157
- 239216
- 239286
- 239337
- 239386
- 239943
- 240269
- 240633
- 240705
- 240903
- 240904
- 241034
- 241223
- 241224
- 241313
A M S, Aligned Medical Solutions, Dsaek Pack-RX, Pack Number AMS12394B, surgical convenience kit
- Lot code
- 237663
- 237901
- 237957
- 238041
- 238084
- 238085
- 238146
- 238197
- 238589
- 239157
- 239216
- 239286
- 239337
- 239386
- 239943
- 240269
- 240633
- 240705
- 240903
- 240904
- 241034
- 241223
- 241224
- 241313
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Pennsylvania, Georgia, California, Washington.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Contamination
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99189
- Recall numbers
- Z-2619-2026 to Z-2622-2026
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
