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Lower risk Medical device recall · FDA · Published May 21, 2026

Windstone Medical Packaging Surgical Kit Recall: Contaminated Alcohol Prep Pad

Windstone Medical Packaging recalls surgical convenience kits with contaminated alcohol prep pads. The kits contain a contaminant (Paenibacillus phoenicis) found during sterilization audits. Affected kits have specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2622-2026Medical deviceWindstone Medical Packaging ›
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Contact the company

Recalling firmWindstone Medical Packaging, Inc.1602 4th Ave N · Billings, MT 59101-1521
✎ GovInfoNow plain-language explainer

Windstone Medical Packaging is recalling surgical convenience kits that include alcohol prep pads contaminated with Paenibacillus phoenicis. This contaminant was discovered during routine sterilization audits, posing a risk of infection during medical procedures. Read more at govinfonow.com/recall/49109-windstone-medical-packaging-surgical-kit-recall-contaminated-alcohol-prep-pad.

Source Summary by GovInfoNow · govinfonow.com/recall/49109-windstone-medical-packaging-surgical-kit-recall-contaminated-alcohol-prep-pad · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2622-2026

Cite this page

“Windstone Medical Packaging Surgical Kit Recall: Contaminated Alcohol Prep Pad.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49109-windstone-medical-packaging-surgical-kit-recall-contaminated-alcohol-prep-pad. Based on FDA recall #Z-2622-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2026%22&limit=1).

The FDA announced on May 21, 2026, that Windstone Medical Packaging is recalling surgical convenience kits due to a contaminant risk. The kits contain Webcol Large Alcohol Prep Pads linked to a prior Cardinal Health recall.

How to tell if you have it

  • Brand: Windstone Medical Packaging
  • Product names: A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack
  • Pack Number: AMS7200D
  • 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: 45 units

The hazard

The kits contain Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health following the discovery of a contaminant, Paenibacillus phoenicis. This contamination was identified during a routine sterilization dose audit.

Context

GovInfoNow's records show Windstone Medical Packaging has 14 other recalls on record since October 24, 2017. Other recent recalls of similar products include Medline Medical Kits Recall: Non-sterile Alcohol Prep Pads Risk (March 16, 2026), Medline Centurion Kits with Contaminated Alcohol Prep Pads Recalled (March 16, 2026), and Medline medical kits recalled for non-sterile alcohol prep pads (March 16, 2026).

How to tell if you have this one

Check the lot numbers on the kit: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

  • Brand
    Windstone Medical Packaging
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of PA, GA, CA, WA.
Recall numberProduct, codes & lotsQuantity
Z-2619-2026A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit; 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, 241313.1080 kits
Z-2620-2026A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit; 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, 241313.200 units
Z-2621-2026A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit; 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, 241313.200 units
Z-2622-2026A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit; 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, 241313.45 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Lot Numbers

    Look for the specific lot numbers listed in the recall notice: 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 it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of PA, GA, CA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Pennsylvania, Washington.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: May 21, 202612. FDA classified it Class I: Jul 1, 202623. Published in FDA’s Enforcement Report: Jul 8, 202632026
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this kit?

The recall is for infection risk during medical procedures, not direct injury. The hazard level is low risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2622-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2622-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA