Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
This recall is currently active, issued October 16, 2025. It was issued by American Contract Systems Inc..
- Company
- American Contract Systems Inc.
- Recall Initiated
- September 4, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0179-2026
- Quantity
- 32,433 total
- Firm Location
- Grimes, IA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.