Medical convenience kits
Medical device recall Z-0172-2026. Published in FDA’s Enforcement Report on Oct 22, 2025.
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 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 5 states named
- 32,433 total 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?
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
32,433 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448; AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042; ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117; ANIR77AM UDI-DI…
Every code shown here, 1,992 characters
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448; AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042; ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117; ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621; CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706; CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A; EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257; EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868; FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258; FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897; HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067; HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A; HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513; IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038; IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486; IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149; LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A; LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A; LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780; MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A; NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A; OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial numbers 47507802 47508002 47508012; RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A; SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A; SFMB55Y UDI-DI 191072229991 Lot 8096711 Bag serial number N/A Lot 8179711 Bag serial numbers 17556181 17557278; STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128; TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A; UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number…
FDA’s list runs to 2,426 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.
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
The states and territories these words name
- Iowa
- Illinois
- Minnesota
- South Dakota
- Washington
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?
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 Sep 4, 2025.
- FDA classified it on Oct 16, 2025.
- FDA’s Enforcement Report published it on Oct 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- American Contract Systems Inc., of Grimes, IA.
- 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.”
- FDA’s list of codes runs to 2,426 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
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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.