Reported Mar 8, 2017 · Terminated

Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy…

Windstone Medical Packaging, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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?

  • Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
Lot codes and dates
    • Lot number and expiration date 100823
    • 10/13/2019 100856
    • 9/5/2019 84375
    • 5/20/2018 84747
    • 7/23/2018 85059
    • 7/21/2018 85549
    • 7/13/2018 85838
    • 8/1/2018 86718
    • 9/5/2018 87103
    • 9/12/2018 87106
    • 9/15/2018 87277
    • 8/10/2019 87347
    • 6/22/2018 87916
    • 6/22/2019 87962
    • 11/15/2018 88047
    • 9/4/2018 88376
    • 12/29/2018 89418
    • 11/12/2018 94736
    • 1/21/2019 95273
    • 6/12/2019 96914
    • 6/15/2019 97450
    • 5/11/2019 98491
    • 9/27/2019 98503
    • 6/6/2019 99369
    • 9/27/2019
Amount recalled
606 kits

This recall covers 124 products

The agency filed one notice per product. You are reading one of them; the other 123 are below.

111 more are in the archive.

Where it was sold

Why it was recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 3, 2017 · Data as of Sep 19, 6:07 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.