Medical Devices Recalls

Hazard: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.

Hazard: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Hazard: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Hazard: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Hazard: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

Hazard: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

Hazard: Potential for brush heads to break.

Hazard: Potential for brush heads to break.

Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Hazard: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

Hazard: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.

Hazard: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Hazard: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Hazard: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Hazard: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Hazard: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.