Windstone Aligned Medical Septo Pack REF AMS1148: Recall for Improper Use Risk
Windstone Medical Packaging recalls Aligned Medical Septo Pack REF AMS11480 with Cardinal Health Salem Sump PVC tubes due to improper use risks. Affected units include specific lot numbers.
Recall notice
Due to convenience kits containing a kit component that is under a recall action for improper use.
Contact the company
What happened, in plain English
Windstone Medical Packaging recalls Aligned Medical Septo Pack REF AMS11480 that contains Cardinal Health Salem Sump PVC tubes. The recall is due to a component being under a separate recall for improper use. This affects medical devices used in clinical procedures. Read more at govinfonow.com/recall/54211-windstone-aligned-medical-septo-pack-ref-ams1148-recall-for-improper.
Source Summary by GovInfoNow · govinfonow.com/recall/54211-windstone-aligned-medical-septo-pack-ref-ams1148-recall-for-improper · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0029-2025
Cite this page
“Windstone Aligned Medical Septo Pack REF AMS1148: Recall for Improper Use Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54211-windstone-aligned-medical-septo-pack-ref-ams1148-recall-for-improper. Based on FDA recall #Z-0029-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0029-2025%22&limit=1).
Why it’s dangerous
The hazard involves a component within the product that is part of a separate recall for improper use. This means the product could pose a risk if used incorrectly, but the exact mechanism isn't specified in the recall notice.
Who’s affected
Medical professionals using the Aligned Medical Septo Pack REF AMS11480 in clinical procedures are most at risk. The specific lot numbers 205273 are affected.
How to tell if you have this one
Check for the product name 'Aligned Medical Septo Pack REF AMS11480' with Cardinal Health Salem Sump PVC tubes. Affected units have lot number 205273.
- Brand
Windstone Medical Packaging- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0027-2025 | 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.; 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 | 642 kits |
| Z-0028-2025 | 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.; 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 | 894 kits |
| Z-0029-2025 | Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.; Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273 | 60 packs |
| Z-0030-2025 | Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.; Catalog Number: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275 | 40 packs |
| Z-0031-2025 | Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.; Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412 | 180 packs |
What to do — step by step
Check Product Details
Look for the product name 'Aligned Medical Septo Pack REF AMS11480' with Cardinal Health Salem Sump PVC tubes and lot number 205273.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Missouri, Ohio, Virginia, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0029-2025 (August 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0029-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.