Data Foundry

Medical device recalls 2024

Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal… — Class II medical device recall Z-0030-2025

Ongoing recall by Windstone Medical Packaging, Inc., reported 2024-10-16, distributed nationwide. Due to convenience kits containing a kit component that is under a recall action for improper use.

Recall numberZ-0030-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmWindstone Medical Packaging, Inc., Billings, MT, United States
Recall initiated2024-08-16
Classified2024-10-08
Reported by FDA2024-10-16
DistributedNationwide (US)
Quantity40 packages
Lot numbers205275
Model numbersAMS11482

Product

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.

Reason for recall

Due to convenience kits containing a kit component that is under a recall action for improper use.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0030-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.