Class IIOngoingZ-0422-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Comp…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 181–192 of 371 recalls
Class IIOngoingZ-0421-2026
Mozarc Medical US LLC recalls MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Comp…
A potential issue with the seal integrity of header bag packaging.
Mozarc Medical US LLCMANov 12, 2025
Class IIOngoingZ-0378-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Fresenius Kabi USA, LL…MANov 5, 2025
Class IIOngoingZ-0377-2026
PHILIPS MEDICAL SYSTEMS recalls Model: Incisive CT for Brazil SKD
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
PHILIPS MEDICAL SYSTEM…MANov 5, 2025
Class IIOngoingZ-0376-2026
PHILIPS MEDICAL SYSTEMS recalls Model: CT 5300
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
PHILIPS MEDICAL SYSTEM…MANov 5, 2025
Class IIOngoingZ-0375-2026
PHILIPS MEDICAL SYSTEMS recalls Model: Incisive CT
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
PHILIPS MEDICAL SYSTEM…MANov 5, 2025
Class IIOngoingZ-0366-2026
Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the…
Siemens Healthcare Dia…MANov 5, 2025
Class IOngoingZ-0136-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Abiomed, Inc.MAOct 29, 2025
Class IIOngoingZ-0166-2026
Philips North America recalls Cardiac Workstation 7000
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Philips North AmericaMAOct 22, 2025
Class IIOngoingZ-0165-2026
Philips North America recalls Cardiac Workstation 5000
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Philips North AmericaMAOct 22, 2025
Class IIOngoingZ-0144-2026
Boston Scientific Corporation recalls LGX Preconnect with TENACIO Pump with InhibiZone
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Boston Scientific Corp…MAOct 22, 2025
Class IIOngoingZ-0143-2026
Boston Scientific Corporation recalls CXR Preconnect with TENACIO Pump with InhibiZone
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Boston Scientific Corp…MAOct 22, 2025