Stop using nowMedical device recall · FDA · Published July 29, 2026
Windstone AMS Convenience Kit: Blue Break-Off Parts Risk
Windstone Medical recalls AMS Convenience Kit (DSAek Pack) with possible blue break-off parts that may detach during use. Affected units include specific lot numbers from 2022-2023. Stop using immediately to avoid potential injury.
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
✎ GovInfoNow plain-language explainer
Windstone Medical is recalling AMS Convenience Kits (DSAek Pack) because they may contain blue break-off parts that detach during use. This could lead to injury if the parts get into the bloodstream. Affected units have specific lot numbers from 2022-2023. Read more at govinfonow.com/recall/1009720-windstone-ams-convenience-kit-blue-break-off-parts-risk.
“Windstone AMS Convenience Kit: Blue Break-Off Parts Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/1009720-windstone-ams-convenience-kit-blue-break-off-parts-risk. Based on FDA recall #Z-3138-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3138-2026%22&limit=1).
Windstone Medical Packaging, Inc. voluntarily recalled AMS Convenience Kit: DSAEK Pack - RX (Part Number AMS12394B) due to potential blue Break-off-Parts from infusion ports, the FDA said on July 29, 2026.
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags that may contain blue Break-off-Parts (BOPs) detached from the infusion port during manipulation.
Context
GovInfoNow's records show Windstone Medical Packaging, Inc. has had 14 other recalls on record since Oct. 24, 2017. Other recent recalls of similar products include AMS Angio Pack Kits: Lidocaine Injection Risk (June 17, 2026) and Windstone Medical Neuro Pack Kits Recall: Potential Endotoxin Variability Risk (June 8, 2026).
How to tell if you have this one
Check the product label for the part number AMS12394B and lot numbers listed in the recall (e.g., 241907, 241223). The kits are sold as medical devices for procedures like DSAEK.
Brand
Windstone Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the kit if you have the affected lot numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, GA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Washington.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-3138-2026 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3138-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.