Reported Feb 28, 2024 · Ongoing

Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

Windstone Medical Packaging, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521

Is this the product you have?

  • Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Lot codes and dates
  • UDIB098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
Amount recalled
475 kits

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Stop using this product now

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.