Class IOngoingZ-2600-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–84 of 426 recalls
Class IOngoingZ-2599-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IIOngoingZ-2579-2026
Philips North America LLC recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following sy…
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Philips North America…MAJul 1, 2026
Class IIOngoingZ-2554-2026
IPG Medical Corporation recalls Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.
IPG Medical Corporatio…MAJul 1, 2026
Class IIOngoingZ-2523-2026
Philips North America LLC recalls Philips Avalon Fetal Monitor
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Philips North America…MAJul 1, 2026
Class IIOngoingZ-2522-2026
Philips North America LLC recalls Philips Avalon Fetal Monitor
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Philips North America…MAJul 1, 2026
Class IOngoingZ-2457-2026
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Abiomed, Inc.MAJun 24, 2026
Class IIOngoingZ-2451-2026
Medtronic Navigation, Inc.-Boxborough recalls Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Medtronic Navigation,…MAJun 24, 2026
Class IOngoingZ-2360-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Abiomed, Inc.MAJun 24, 2026
Class IIOngoingZ-2413-2026
Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Boston Scientific Corp…MAJun 17, 2026
Class IIOngoingZ-2401-2026
Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in…
Fresenius Medical Care…MAJun 17, 2026
Class IIOngoingZ-2354-2026
Philips North America LLC recalls DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Philips North America…MAJun 17, 2026