FDA Medical devices recall ·
Aligned Medical Tonsil Tray recall
- Recall number
- Z-0027-2025
- 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
- 642 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Aligned Medical Tonsil Tray REF AMS9300A 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: AMS9300A UDI-DI code: B098AMS9300A0 Lot Numbers: 168030 171362 172981 177913 179608 181537 185126 189873 189874 196460 196461 198850 200902 206846 208255 209391
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-0027-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.