April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE C
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Mod
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
Hazard: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
April 23, 2025Medical DevicesFDA
Channel Medsystems, Inc. recalls Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70
Hazard: Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
April 23, 2025Medical DevicesFDA
Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile
Hazard: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
April 23, 2025Medical DevicesFDA
Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile
Hazard: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
April 23, 2025Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)
Hazard: Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc
Hazard: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V
Hazard: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version
Hazard: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc
Hazard: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V
Hazard: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version
Hazard: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
April 23, 2025Medical DevicesFDA
Thoratec LLC recalls HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear
Hazard: Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
April 23, 2025Medical DevicesFDA
Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for
Hazard: The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B;
Hazard: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
April 23, 2025Medical DevicesFDA
Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Hazard: The devices are missing the laser marked depth markings.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn CP150 Electrocardiograph:
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn CONNEX Accessory Power Management Stand:
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 23, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor (CVSM):
Hazard: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
April 23, 2025Medical DevicesFDA
Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod
Hazard: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.