Class IIOngoingZ-1315-2025
DePuy Mitek, Inc., A Johnson & Johnson Co. recalls COR Disposable Kit
Device is missing the pin in the graft loader component.
DePuy Mitek, Inc., a J…MAMar 19, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 373–384 of 415 recalls
Class IIOngoingZ-1314-2025
DePuy Mitek, Inc., A Johnson & Johnson Co. recalls COR Disposable Kit
Device is missing the pin in the graft loader component.
DePuy Mitek, Inc., a J…MAMar 19, 2025
Class IIOngoingZ-1307-2025
CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It…
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
CardioFocus, Inc.MAMar 19, 2025
Class IIOngoingZ-1270-2025
Telcare, LLC recalls Philips Connected Blood Glucose Meter
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System..…
Telcare, LLCMAMar 12, 2025
Class IIOngoingZ-1170-2025
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog N…
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Hologic, IncMAFeb 19, 2025
Class IIOngoingZ-1110-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX550. Model Number: 866066
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1109-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX500. Model Number: 866064
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1108-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX450. Model Number: 866062
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1107-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1106-2025
Philips North America LLC recalls IntelliBridge EC10 Module. Model Number: 865115
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1099-2025
Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Design…
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Belmont Instrument LLCMAFeb 12, 2025
Class IOngoingZ-1019-2025
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more.…
Fresenius Kabi USA, LL…MAFeb 12, 2025