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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Windstone Medical Packaging, Inc.: Medical Convenience Kits Recalled for Defective Suction Tube Components

Agency Publication Date: October 8, 2024
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Summary

Windstone Medical Packaging is recalling 1,816 Aligned Medical tonsil and surgery kits because they contain Cardinal Health Salem Sump PVC tubes that were previously recalled for improper use instructions or defects. These convenience kits, including the Tonsil Tray and various surgical packs, were distributed across five states and are used in clinical procedures. No injuries have been reported to date, but the underlying component issue prompted this voluntary action to ensure patient safety during medical treatments.

Risk

The kits contain a suction tube component that is under separate recall; using these potentially defective components during surgical or clinical procedures could lead to improper device performance or complications during patient care.

What You Should Do

  1. Identify if you have any of the affected Aligned Medical kits by checking the Catalog and Lot Numbers on your packaging. Affected products include the Aligned Medical Tonsil Tray (REF AMS9300A), Tonsil ENT Pack (REF AMS9977), Septo Pack (REF AMS11480), T and A Pack (REF AMS11482), and Tonsil Pack (REF AMS14809).
  2. For the Tonsil Tray (AMS9300A), check for lot numbers: 168030, 171362, 172981, 177913, 179608, 181537, 185126, 189873, 189874, 196460, 196461, 198850, 200902, 206846, 208255, and 209391.
  3. For the Tonsil ENT Pack (AMS9977), check for lot numbers: 158265, 164363, 167626, 169363, 173648, 178341, 186343, 192237, 193165, 194502, 196521, 201447, 202990, 205757, 208807, 210226, 211594, and 212449.
  4. For other packs, look for Septo Pack lot 205273, T and A Pack lot 205275, or Tonsil Pack lots 192737, 194922, 200224, 200950, and 203412.
  5. If you possess an affected kit, immediately stop using it and quarantine the product to prevent clinical use.
  6. Contact your healthcare provider or Windstone Medical Packaging at their Billings, Montana facility to discuss the return process or for further instructions regarding the defective Cardinal Health component.
  7. Contact the FDA at 1-888-463-6332 or visit www.fda.gov for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Aligned Medical Tonsil Tray REF AMS9300A
Model / REF:
AMS9300A
UDI-DI: B098AMS9300A0
Lot Numbers:
168030
171362
172981
177913
179608
181537
185126
189873
189874
196460
196461
198850
200902
206846
208255
209391
Product: Aligned Medical Tonsil ENT Pack REF AMS9977
Model / REF:
AMS9977
UDI-DI: B098AMS99770
Lot Numbers:
158265
164363
167626
169363
173648
178341
186343
192237
193165
194502
196521
201447
202990
205757
208807
210226
211594
212449
Product: Aligned Medical Septo Pack REF AMS11480
Model / REF:
AMS11480
UDI-DI: B098AMS114800
Lot Numbers:
205273
Product: Aligned Medical T and A Pack REF AMS11482
Model / REF:
AMS11482
UDI-DI: B098AMS114820
Lot Numbers:
205275
Product: Aligned Medical Tonsil Pack REF AMS14809
Model / REF:
AMS14809
UDI-DI: B098AMS148090
Lot Numbers:
192737
194922
200224
200950
203412

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95306
Status: Active
Manufacturer: Windstone Medical Packaging, Inc.
Sold By: Clinical facilities; Hospitals
Manufactured In: United States
Units Affected: 5 products (642 kits; 894 kits; 60 packs; 40 packs; 180 packs)
Distributed To: California, Missouri, Ohio, Virginia, Wyoming
Agency Last Updated: October 10, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.