The Recall Desk
SevereFDA (Devices)·Z-2620-2026·Announced 2026-07-08

Thyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination

Windstone Medical Packaging is recalling AMS Thyroid FNA Pack-RX surgical kits due to contamination with Paenibacillus phoenicis bacteria found in included Webcol alcohol prep pads.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I medical device recall. Per the rubric, FDA Class I recalls meet the Severe (score 4) threshold or higher; no deaths or serious injuries are reported in the source, so the score is 4.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling the AMS, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX (Pack Number AMS17729) surgical convenience kit due to contamination discovered in the Webcol Large Alcohol Prep Pads included in the kits. Cardinal Health identified the contaminant, Paenibacillus phoenicis, during a routine sterilization dose audit.

The recalled kits were distributed nationwide to facilities in Pennsylvania, Georgia, California, and Washington. A total of 200 units with 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, and 241313 are affected.

Healthcare facilities that received these kits should discontinue use immediately and contact Windstone Medical Packaging, Inc. for further instructions. This is a Class I recall, indicating a serious potential health risk.

The recalled product

Product
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, 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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

Same hazard · bacterial contamination

See all →