Various Custom Surgical Instrument Disposable Kits
Medical device recall Z-0881-2023. Published in FDA’s Enforcement Report on Jan 11, 2023.
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 Jan 11, 2023. Copied from openFDA on Oct 24, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 15 states named
- 9,489 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?
Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
9,489 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
Part Numbers / Product Description / UDI Code: 26000004M Custom Lasik Kit B09826000004M0 Lot Numbers 172743 175939 178701 AMS10411A Nasal Endoscopy Pack B098AMS10411A0 Lot Numbers 167289 171449 176800 AMS10710A Ultrasound Tray w/PDI…
Every code shown here, 1,999 characters
Part Numbers / Product Description / UDI Code: 26000004M Custom Lasik Kit B09826000004M0 Lot Numbers 172743 175939 178701 AMS10411A Nasal Endoscopy Pack B098AMS10411A0 Lot Numbers 167289 171449 176800 AMS10710A Ultrasound Tray w/PDI B098AMS10710A0 Lot Numbers 165400 170502 172266 174545 178063 AMS11941 Total Knee Pack B098AMS119410 Lot Numbers 167985 172632 AMS12138B Eye Pack B098AMS12138B0 Lot Number 173532 AMS12278B Body Pack B098AMS12278B0 Lot Numbers 169016 171534 173220 174960 176107 178175 AMS12341A Hassan Pack B098AMS12341A0 Lot Number 167836 AMS12341B Hassan Pack B098AMS12341B0 Lot Numbers 170376 176035 178108 AMS12343A Meldrum Pack B098AMS12343A0 Lot Numbers 169907 173805 178357 AMS12359B Neuro Pack B098AMS12359B0 Lot Numbers 169315 174926 177785 AMS12520 Total Hip Pack B098AMS125200 Lot Number 172089 AMS12608 Extremity Pack B098AMS126080 Lot Numbers 167069 167271 171686 172416 173221 175365 AMS12610 Shoulder Pack B098AMS126100 Lot Numbers 165469 176734 179262 AMS12636 Dr. Thompson Pack B098AMS126360 Lot Numbers 169693 169902 170466 173025 174576 176208 177411 180470 AMS12689A Custom Pack B098AMS12689A0 Lot Numbers 169549 171027 172750 173642 175088 176507 177771 179109 180349 AMS12753 Breast Pack B098AMS127530 Lot Numbers 168384 171578 176335 AMS12754 Abdominoplasty Pack B098AMS127540 Lot Numbers 168546 171086 AMS12769 Minor Pack B098AMS127690 Lot Numbers 169398 170647 173968 176964 AMS12926 Shoulder Pack B098AMS129260 Lot Numbers 172790 176337 AMS12927 Retina Pack B098AMS129270 Lot Numbers 172376 177356 177598 180851 181069 AMS13428 Hand Pack B098AMS134280 Lot Number 173569 AMS2120D Plastics Tray B098AMS2120D0 Lot Numbers 174742 176986 AMS2890(B Basic Biopsy Tray B098AMS2890B0 Lot Numbers 174253 176930 182598 AMS3824(A Myelogram Tray - RX B098AMS3824A0 Lot Number 177781 AMS4022F Lami Pack B098AMS4022F0 Lot Numbers 168799 168800 168801 169653 171413 171414 172773 173794 174413 177139 177377 177705 177847 177849 178356 178358 179492 179493 180260 AMS4371C…
FDA’s list runs to 4,374 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.
The states and territories these words name
15 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Guam
- Indiana
- North Carolina
- New Jersey
- Nevada
- Oklahoma
- Pennsylvania
- Tennessee
- Texas
- Wisconsin
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.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Nov 1, 2022.
- FDA classified it on Jan 4, 2023.
- FDA’s Enforcement Report published it on Jan 11, 2023.
FDA, Device recall enforcement reports. Released Oct 23, 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: E-Mail.
FDA, Device recall enforcement reports. Released Oct 23, 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.”
- FDA’s list of codes runs to 4,374 characters; the first part is shown here, and the rest is on FDA’s record.
- 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 23, 2026 and checked Oct 23, 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 24, 2026.