American Contract Systems recalled 32,433 medical convenience kits nationwide after finding re-gassed devices from EO sterilization. The recall affects five product lines with UDI-DI codes and Lot numbers. The re-gassing process has not been validated for multiple sterilization cycles, calling into question product safety and effectiveness. Health providers and patients should stop using these kit
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Medical convenience kits used in clinical settings to streamline patient care. These kits include cataract, eye, and retinal packs.
Re-gassing after EO sterilization may affect sterility and product performance leading to potential infection risk if compromised.
This recall is not clearly part of a broader industry pattern in the provided data.
Disruption in clinical workflows if kits are suspected unsafe; potential waste of sterile supplies; impact on patient safety.
Look on the kit label for UDI-DI and lot numbers; FDA recall page Z-0185-2026
Recall processing timelines vary; consult FDA and manufacturer communications for refunds/replacements; expect weeks to months
Keep product packaging, labeling, recall notices, and correspondence with the manufacturer.
Brand: American Contract Systems. Models: BFCT04X UDI-DI 191072225955 Lot 7992111; CMEY17AI UDI-DI 191072211514 lot 8082511; PERP25AQ UDI-DI 191072199720 lot 8078511; RFEY50AC UDI-DI 191072202918 lot 8048811; UIVT47AS UDI-DI 191072224569 lot 7969711. Sold nationwide in the United States. Distribution states: SD, IA, MN, WA, IL. Quantity: 32,433 units. Classification: Class II. Recall date: 2025-09-04. Report date: 2025-10-22.
No specific injuries or incidents are reported in the provided data.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
BMW recalls 2025-2026 X1 and X2 models plus MINI Cooper and Countryman variants for front seat belt retractors with damaged torsion bars. The defect may fail to restrain occupants in a crash. Dealers will replace both front retractors at no cost. Owner letters begin November 7, 2025. VIN lookup will be available on NHTSA.gov the same day.