Vehicle Apr 24, 2025
General Motors LLC (GM) is recalling certain 2021-2024 Cadillac Escalade and Escalade ESV, Chevrolet Silverado 1500, Suburban, and Tahoe, GMC Sierra 1500, Yukon, and Yukon XL vehicles…
hard parts internal/mechanical General Motors, LLC
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
Lack of sterility assurance for closed suction catheter systems
Class I FDA: Ongoing Avanos Medical, Inc.
Medical Device Apr 23, 2025
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Class II FDA: Ongoing Abbott Medical
Medical Device Apr 23, 2025
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Class II FDA: Ongoing GE Medical Systems, LLC
Medical Device Apr 23, 2025
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate…
Class I FDA: Ongoing Tandem Diabetes Care, Inc.
Medical Device Apr 23, 2025
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
Class II FDA: Ongoing Channel Medsystems, Inc.
Medical Device Apr 23, 2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Class II FDA: Ongoing Abbott Diagnostics Scarborough, Inc.
Medical Device Apr 23, 2025
Lack of sterility assurance for closed suction catheter systems
Class I FDA: Ongoing Avanos Medical, Inc.
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
Lack of sterility assurance for closed suction catheter systems
Class I FDA: Ongoing Avanos Medical, Inc.
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II FDA: Ongoing Baxter Healthcare Corporation
Medical Device Apr 23, 2025
Potential for collimator to fall as a result of incorrect installation.
Class II FDA: Ongoing Philips North America LLC
Medical Device Apr 23, 2025
Lack of sterility assurance for closed suction catheter systems
Class I FDA: Ongoing Avanos Medical, Inc.
Medical Device Apr 23, 2025
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Class II FDA: Ongoing Maquet Cardiovascular, LLC
Medical Device Apr 23, 2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Apr 23, 2025
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Class II FDA: Ongoing Stryker GmbH
Medical Device Apr 23, 2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Class II FDA: Ongoing Abbott Diagnostics Scarborough, Inc.