FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- Recall number
- Z-2620-2026
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- Status
- Open, Classified
- Initiated
- 2026-05-21
- Posted
- 2026-07-01
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 200 units
- Distribution
- US Nationwide distribution in the states of PA, GA, CA, WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGR
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28