A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

FDA device recall Z-2620-2026 · posted 2026-07-01 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

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.

Action taken

AMS ALIGNED MEDICAL SOLUTIONS issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/21/2026 via email. The notice explained the issue, potential risk, and requested the following: "AMS requests that you undertake the following activities: 1. Immediately check your inventory for the recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE CARDINAL HEALTH announced the recall of 5110 Webcol" Large Alcohol Prep Pad contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. " At the time the kit is opened for use any Cardinal Alcohol Prep Pad should be identified and set aside. " The recalled Cardinal Alcohol Prep Pad should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand." For questions or concerns: fieldcorrectiveaction@alignedmedicalsolutions.com.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

OGR

Quantity affected

200 units

Distribution

US Nationwide distribution in the states of PA, GA, CA, WA.

Date initiated

2026-05-21

Date posted

2026-07-01

Location

Billings, MT