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Showing 7421–7440 of 35916 results

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COBALT XT HF CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

Cobalt XT DR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

Stryker Blueprint Software (Tornier) – case planning bug (2024)

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

High

FDAApr 16, 2024Nationwide• Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France

CARDIOHELP-i System (Maquet) – patient leakage current (2024)

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

FDAApr 15, 2024Nationwide• Maquet Medical Systems USA

BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Tri-Staple 2.0 Reload (Unknown) – cartridge damage risk (2024)

Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

FDAApr 15, 2024Nationwide

Maserati Ghibli (Maserati) – fuel line sensor issue (2024)

Maserati North America, Inc. (Maserati) is recalling certain 2021-2022 Quattroporte and Ghibli vehicles. The fuel line sensor housing may crack and leak fuel.

NHTSAApr 15, 2024Nationwide• MASERATI

BD Pyxis Anesthesia Station (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Incisive CT X-Ray System (Philips) – mounting box compromise (2024)

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

FDAApr 15, 2024Nationwide• Philips North America Llc

BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedStation 4000 System (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Total Knee Arthroplasty System (Stryker) – software error (2024)

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

FDAApr 15, 2024Nationwide• Stryker Orthopaedics

BD Pyxis Anesthesia Station 4000 (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedStation (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Organic Black Chia Seeds (Walmart) – Salmonella Risk (2024)

Salmonella contamination

FDAApr 15, 2024AL, CA, CO +9 more• NATURAL SOURCING INTERNATIONAL,LLC

MyoSPECT System (GE Medical) – lead cover handle risk (2024)

There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

FDAApr 15, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Ford Maverick (Ford) – incorrect loading label (2024)

Ford Motor Company (Ford) is recalling certain 2024 Maverick vehicles. The tire and loading information label may state the incorrect vehicle capacity, tire pressure, and spare tire size. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 110, "Tire Selection and Rims."

NHTSAApr 12, 2024Nationwide• FORD

Forest River Cardinal (Forest River) – towing hitch issue (2024)

Forest River, Inc. (Forest River) is recalling certain 2024 Cardinal and Wildcat Fifth Wheels trailers. The operator may utilize the rear towing hitch without locking the turning point fifth wheel hitch into the "Conventional Transport" position.

NHTSAApr 12, 2024Nationwide• FOREST RIVER

APTUS TriLock Screw (Medartis) – incorrect length (2024)

Screw is 16mm long instead of 22mm long.

FDAApr 12, 2024Nationwide• Medartis Inc.

Ford Bronco Sport (Ford) – control module failure (2024)

Ford Motor Company (Ford) is recalling certain 2021-2024 Bronco Sport and 2022-2023 Maverick vehicles. The body and power train control modules may fail to detect a change in the 12-volt battery state of charge.

NHTSAApr 12, 2024Nationwide• FORD

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