Recall archive / FDA device enforcement
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE... — FDA record Z-0179-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- American Contract Systems Inc.
- Quantity
- 32,433 total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0179-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879; LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175; OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382; RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909; UIGN82M UDI-DI 191072106674 lot 8084811 bag serial numbers 17391081 17391091 17391111 17391171 lot 8445711 bag serial numbers 17683242 lot 8530511 bag serial numbers 17712404; UIHY16AE UDI-DI 00191072234117 Lot 8171811 N/A * If bag serial number is listed as "n/a", then entire lot is affected |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Sep 4, 2025
- Center classification date
- Oct 16, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.