Class IIOngoingZ-1038-2026
Medicrea International recalls Medicrea
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Medicrea InternationalJan 21, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,405–1,416 of 3,866 recalls
Class IIOngoingZ-1024-2026
REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820…
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact.…
REPLIGEN CORPORATIONMAJan 21, 2026
Class IIOngoingZ-1018-2026
Canon Medical System, USA, INC. recalls VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems.…
Canon Medical System,…CAJan 21, 2026
Class IIOngoingZ-1017-2026
Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems.…
Canon Medical System,…CAJan 21, 2026
Class IIOngoingZ-1037-2026
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink I…
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Integra LifeSciences C…NJJan 14, 2026
Class IIOngoingZ-1036-2026
Integra LifeSciences Corp. (NeuroSciences) recalls Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENS…
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Integra LifeSciences C…NJJan 14, 2026
Class IIOngoingZ-1035-2026
Medline Industries, LP recalls Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which ma…
Medline Industries, LPILJan 14, 2026
Class IIOngoingZ-1034-2026
IMRIS Imaging Inc recalls Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 11…
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of…
IMRIS Imaging IncMNJan 14, 2026
Class IIOngoingZ-1033-2026
Philips North America LLC recalls Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Philips North America…MAJan 14, 2026
Class IIOngoingZ-1032-2026
Securitas Healthcare LLC recalls Arial 900 MHz Call Station
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergenc…
Securitas Healthcare L…NEJan 14, 2026
Class IIOngoingZ-1031-2026
Securitas Healthcare LLC recalls Arial 900 MHz Call Station
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergenc…
Securitas Healthcare L…NEJan 14, 2026
Class IIOngoingZ-1030-2026
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2
Device packaged in incorrect outer box carton.
Abiomed, Inc.MAJan 14, 2026