Z-0181-2026Class II

Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B...

Name: Z-0181-2026 Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B...
Creator: American Contract Systems Inc.
Published: 2025-09-04
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-09-04 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems Inc. began a recall of Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK on 2025-09-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0181-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-04
Posted: 2025-10-16
Recalling firm: American Contract Systems, Inc.
Product: Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Product code: OHM Cesarean Section Tray
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Quantity in commerce: 32,433 total
Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Product codes and lots: FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296; HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637; HSCB90B UDI-DI 191072141606 Lot 8083511 Bag serial numbers 47506618 47508489 * If bag serial number is listed as "N/A", then whole lot is affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0171-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0172-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0173-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0174-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0175-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0176-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0177-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0178-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0179-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0180-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0181-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0182-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0183-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0184-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0185-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0186-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0187-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code OHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)