Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic…
Medical device recall Z-1267-2017. Published in FDA’s Enforcement Report on Mar 8, 2017.
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 Mar 8, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 26 states named in where it went
- 2388 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 of the custom Aligned Medical Solutions (AMS) kits 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?
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
2388 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot number and expiration date 100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018…
Every code shown here, 1,082 characters
Lot number and expiration date 100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018 86859, 8/18/2018 86939, 11/22/2018 87105, 9/15/2018 87269, 9/30/2018 87351, 9/15/2018 87447, 11/11/2018 87942, 9/23/2018 88172, 12/3/2018 88282, 9/7/2018 88368, 9/5/2018 88846, 12/11/2018 88887, 12/7/2018 89004, 10/8/2018 89160, 12/1/2018 89438, 11/22/2018 89512, 10/9/2018 89716, 1/9/2019 89743, 12/3/2018 89811, 12/1/2018 94572, 12/15/2018 94705, 12/15/2018 94751, 1/4/2019 94853, 1/27/2019 94935, 1/25/2019 95293, 1/26/2019 95412, 1/25/2019 95936, 1/11/2019 95974, 5/29/2019 96023, 1/16/2019 96255, 1/2/2019 96410, 3/7/2019 96566, 3/9/2019 96678, 5/24/2019 96913, 5/22/2019 97124, 5/12/2019 97410, 6/3/2019 97577, 5/1/2019 97780, 6/15/2019 98017, 6/29/2019 98312, 6/24/2019 98478, 6/29/2019 98502, 6/6/2019 98663, 6/28/2019 98633, 6/30/2019 99172, 6/12/2019 99581, 6/27/2019 99703, 9/27/2019 99843, 9/30/2019 99887, 9/11/2019 99913, 9/23/2019
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.
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
The states and territories these words name
26 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- Nevada
- Ohio
- Pennsylvania
- Texas
- Utah
- Virginia
- Washington
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jan 11, 2017.
- FDA classified it on Feb 28, 2017.
- FDA’s Enforcement Report published it on Mar 8, 2017.
- FDA terminated it on May 3, 2017.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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
-
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.