Class II U.S. Food and Drug Administration

American Contract Systems Inc. Medical convenience kits recall: Identified products were re-gassed (sterilized more than once) after

Recall published 1+ years ago

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.

The hazard: Harmful chemical exposure

The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

What the notice says: 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.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0172-2026
Published
October 22, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
American Contract Systems Inc.
Product type
Medical devices
Units affected
32,433 total
Distribution
Nationwide
Made in
United States
Lot / code info
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 68703044; UDMA50X UDI-DI 191072172587 Lot 8084711 Bag serial number 17390548 Lot 8183611 Bag serial number 17554620; UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A; UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A; UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422; UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A * If "N/A" for bag serial number, then whole lot is affected
UPC codes
191072229281, 191072185082, 191072214300, 191072236692, 191072203496, 191072186409, 191072215093, 191072224064, 191072159236, 191072157256, 191072212580, 191072212672, 191072212399, 191072224187, 191072159960, 191072227232, 191072158666, 191072158680, 191072237880, 191072231444

Products covered by this recall

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)

Check your product

The notice names 41 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 191072229281
  • 191072185082
  • 191072214300
  • 191072236692
  • 191072203496
  • 191072186409
  • 191072215093
  • 191072224064
  • 191072159236
  • 191072157256
  • 191072212580
  • 191072212672
  • 191072212399
  • 191072224187
  • 191072159960
  • 191072227232
  • 191072158666
  • 191072158680
  • 191072237880
  • 191072231444

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • is affected — 32
  • 433 total

Serial number

On the rating plate, often next to the date of manufacture.

  • 47384448
  • 68117042
  • 17487164 17488117
  • 58588193 58588194 68563615 68663621
  • 68642706
  • 68198257
  • 68194868
  • 47864258
  • 68152897
  • 68244067
  • 17427513
  • 68048038
  • 68154486
  • 68200149
  • 68642780
  • 47507802 47508002 47508012
  • 17506128
  • 68703044
  • 68047422

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Chemical

American Contract Systems Inc. — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

  1. Stop using the product and keep it away from children and pets.
  2. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  3. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  4. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

Company contact: American Contract Systems Inc. — 1601 Se Gateway Dr Ste 120, Grimes, IA, 50111-5223

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was American Contract Systems Inc. medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 191072229281, 191072185082, 191072214300; lot code is affected — 32, 433 total. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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