October 29, 2025Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect
Hazard: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
October 29, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20
Hazard: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
October 22, 2025Medical DevicesFDA
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
Hazard: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 me
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backche
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Prod
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio
Hazard: IV sets may leak.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits IHDC30R D AND C PACK
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCN
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BA
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Hazard: 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.
October 22, 2025Medical DevicesFDA
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CEN
Hazard: 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.