Class IIOngoingZ-3328-2026
SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger Hi…
Due to blood-to-glycol leak in the heat exchanger.
SPECTRUM MEDICAL SRLOct 7, 2026
Recalls: Process design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 30 recalls
Class IIOngoingZ-3327-2026
SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger Hi…
Due to blood-to-glycol leak in the heat exchanger.
SPECTRUM MEDICAL SRLOct 7, 2026
Class IIOngoingZ-3253-2026
Criticare Technologies, Inc. recalls nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Criticare Technologies…RISep 30, 2026
Class IIOngoingZ-3226-2026
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head
The proximal thread depth of the spinal device is out of design specification.
SEASPINE ORTHOPEDICS C…CASep 30, 2026
Class IIOngoingZ-2982-2026
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Medtronic MiniMed, Inc…CAAug 26, 2026
Class IIOngoingZ-2981-2026
Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Medtronic MiniMed, Inc…CAAug 26, 2026
Class IIOngoingZ-2980-2026
Medtronic MiniMed, Inc. recalls MiniMed 640G Insulin Pump
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog…
Medtronic MiniMed, Inc…CAAug 26, 2026
Class IIOngoingZ-2886-2026
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
United Orthopedic Corp…Aug 12, 2026
Class IIOngoingZ-2885-2026
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
United Orthopedic Corp…Aug 12, 2026
Class IIOngoingZ-2884-2026
United Orthopedic Corp. recalls Brand Name: USTAR II Knee System Product Name: Hinge Box Trial
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
United Orthopedic Corp…Aug 12, 2026
Class IIOngoingZ-2883-2026
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: PSA Box Trial
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
United Orthopedic Corp…Aug 12, 2026
Class IIOngoingZ-2859-2026
Innovasis, Inc recalls Anti-Torque
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mat…
Innovasis, IncUTAug 12, 2026