The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2621-2026·Announced 2026-07-08

Preop Kit-NS surgical kits recalled for bacterial contamination

A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I recall. Per the rubric, FDA Class I recalls are classified as Severe (4) or Critical (5); since no deaths or serious injuries are reported in the source, the score is 4 (Severe).

Plain-English summary

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS surgical convenience kits (Pack Number AMS18227) manufactured by Windstone Medical Packaging, Inc. are being recalled. The kits contain Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after a contaminant, Paenibacillus phoenicis, was discovered during a routine sterilization dose audit.

Approximately 200 units were distributed nationwide across Pennsylvania, Georgia, California, and Washington. Affected lot codes include: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, and 241313.

Customers who have received these kits should stop using them immediately and contact Windstone Medical Packaging, Inc. or their distributor for instructions regarding return or replacement.

The recalled product

Product
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kit
Hazard
Affected units
200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI/DI none
  • Lot Codes: 237663
  • 237901
  • 237957
  • 238041
  • 238084
  • 238085
  • 238146
  • 238197
  • 238589
  • 239157
  • 239216
  • 239286
  • 239337
  • 239386
  • 239943
  • 240269
  • 240633
  • 240705
  • 240903

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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