A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Summary
The FDA issued a Class I for A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical by Windstone Medical Packaging, Inc.. Reason: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) d.
Details
Source
Device Recall
External ID
Z-2619-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Lot/Code Info: 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.
Quantity Affected: 1080 kits
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.
Distribution
US Nationwide distribution in the states of PA, GA, CA, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-21
Company
Billings, MT
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2619-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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