FDA Medical devices recall ·
Aligned Medical Tonsil ENT Pack recall
- Recall number
- Z-0028-2025
- Date
- (initiated August 16, 2024)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 894 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Why was it recalled?
Due to convenience kits containing a kit component that is under a recall action for improper use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: AMS9977 UDI-DI code: B098AMS99770 Lot Numbers: 158265 164363 167626 169363 173648 178341 186343 192237 193165 194502 196521 201447 202990 205757 208807 210226 211594 212449
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
States: California Missouri Ohio Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0028-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.