Aligned Medical T and A Pack Recalled for Component Misuse Risk
Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall is based on a component within the kit being subject to a separate recall action, representing a precautionary measure. The hazard related to improper use is theoretical with no confirmed patient harm.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the Aligned Medical T and A Pack (Catalog Number AMS11482, UDI-DI B098AMS114820, Lot Number 205275). This convenience kit is used in general clinical procedures and contains Cardinal Health Salem Sump PVC tubes.
The kit is being recalled because it contains a component that is subject to a separate recall action due to improper use.
The recalled packs were distributed nationwide in the United States in California, Missouri, Ohio, Virginia, and Wyoming. A total of 40 packs were distributed.
Healthcare facilities and clinicians who have received this product should cease use and contact the manufacturer for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275
Distribution
Part of a larger recall action
This product is one of 5 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Windstone Medical Packaging, Inc.
See all →- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- HighMedical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
Same hazard · improper use
See all →- ModerateGenius Review Station Display Modified Outside Validated Configuration
FDA (Devices) · 2026-05-06
- HighChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
FDA (Devices) · 2025-06-11
- ModeratePre-filled Water Syringe recalled for improper use contamination
FDA (Devices) · 2025-06-11
- HighBD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market
FDA (Devices) · 2025-04-09
- ModerateOlympus Gastrointestinal Videoscope Drying Instructions Clarified
FDA (Devices) · 2024-11-27
Similar recalls
- SevereSurgical Kit with Saline Recalled Over Sterility Assurance Issue
FDA (Devices) · 2024-02-28
- HighWindstone Medical Recalls Vascular Packs Due to Sterility Compromise
FDA (Devices) · 2017-03-08
- HighWindstone Medical Packaging Recalls Plastic Surgery Packs Due to Sterility Concerns
FDA (Devices) · 2017-03-08
- HighWindstone Medical Packaging Recalls Lower Extremity Packs Due to Sterility Concerns
FDA (Devices) · 2017-03-08
- HighWindstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- ModerateMedical Device Swabs Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-05-25