Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706…
Medical device recall Z-0183-2017. Published in FDA’s Enforcement Report on Oct 26, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 26, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 12 states named
- 3829 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
3829 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers/Expiration Dates: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015…
Every code shown here, 1,880 characters
Lot Numbers/Expiration Dates: 59926 5/26/2014 60668 8/14/2014 70310 1/17/2015 68666 1/20/2015 62745 1/29/2015 69836 2/9/2015 66661 4/25/2015 59586 7/22/2015 60264 7/23/2015 59204 8/5/2015 61382 8/20/2015 63063 9/4/2015 61012 9/11/2015 61013 9/14/2015 64817 10/10/2015 61618 10/15/2015 61383 10/18/2015 64593 10/19/2015 64969 11/3/2015 65776 11/5/2015 64394 11/14/2015 63778 11/15/2015 65580 11/16/2015 61938 11/17/2015 62567 11/18/2015 61626 11/20/2015 66917 11/21/2015 61343 11/22/2015 66393 11/23/2015 62154 11/23/2015 66584 11/26/2015 63230 12/18/2015 66183 12/24/2015 64380 1/4/2016 63989 1/7/2016 63404 1/9/2016 78771 1/9/2016 63992 1/11/2016 64696 1/13/2016 64395 1/14/2016 63779 1/18/2016 73914 3/2/2016 73298 3/16/2016 73714 3/23/2016 56866 5/22/2016 57094 5/23/2016 57068 5/24/2016 77013 6/4/2016 70913 6/6/2016 74518 6/8/2016 57067 6/10/2016 71703 6/14/2016 57216 6/19/2016 76121 6/21/2016 57511 6/22/2016 67763 7/1/2016 69284 7/16/2016 70977 7/17/2016 72321 7/17/2016 58092 7/20/2016 67097 7/23/2016 58319 7/25/2016 77988 7/30/2016 77053 7/30/2016 78132 7/30/2016 77721 7/30/2016 58935 8/21/2016 59057 8/22/2016 57588 8/23/2016 72894 8/25/2016 68286 8/25/2016 59210 8/28/2016 70323 9/11/2016 68755 9/22/2016 69925 9/22/2016 70567 9/24/2016 68888 9/26/2016 70568 9/28/2016 77749 10/21/2016 70298 10/23/2016 69708 10/24/2016 71084 10/28/2016 69471 10/31/2016 69083 11/24/2016 71424 12/11/2016 72789 1/10/2017 72318 1/10/2017 70981 1/21/2017 72960 1/21/2017 73548 1/22/2017 73097 3/13/2017 73917 4/18/2017 74272 4/24/2017 74822 5/14/2017 75045 5/24/2017 74474 5/25/2017 75351 6/20/2017 77597 7/19/2017 75822 7/23/2017 76486 7/27/2017 74084 8/4/2017 76956 8/7/2017 79077 9/10/2017 78131 9/19/2017 77601 10/9/2017 77531 10/10/2017 78761 11/5/2017 78757 11/9/2017 79263 11/23/2017 78470 1/5/2018 79339 1/16/2018 80751 1/23/2018 79337 1/25/2018 79604 2/25/2018 80517 2/25/2018
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
The states and territories these words name
- California
- Florida
- Georgia
- Illinois
- Kansas
- Louisiana
- Michigan
- New Jersey
- Nevada
- Texas
- Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 22, 2015.
- FDA classified it on Oct 20, 2016.
- FDA’s Enforcement Report published it on Oct 26, 2016.
- FDA terminated it on Oct 25, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Windstone Medical Packaging, Inc., of Billings, MT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.