Agency classClass IOur severity:Severe FDA (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.

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 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: bacterial-contamination
paenibacillus-phoenicis
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 →

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

High
Windstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
Moderate
AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
High
Medical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05

Same hazard · bacterial contamination