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Showing 12301–12320 of 35905 results

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Abbott Molecular, Inc.: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

FDANov 22, 2022Nationwide• Abbott Molecular, Inc.

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDANov 22, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

2023 BMW I7 Recall: ELECTRICAL SYSTEM

BMW of North America, LLC (BMW) is recalling certain 2023 BMW 740i, 760i xDrive, and i7 xDrive60 vehicles. The telematics control unit may not transmit the vehicle location information to emergency responders.

NHTSANov 21, 2022Nationwide• BMW

2023 WINNEBAGO REVEL Recall: STRUCTURE:BODY

Winnebago Industries, Inc. (Winnebago) is recalling certain 2021-2023 Revel motorhomes. The retractable awning may extend unintentionally during transit.

NHTSANov 21, 2022Nationwide• WINNEBAGO

2020 AUDI S6 Recall: ELECTRICAL SYSTEM

Volkswagen Group of America, Inc. (Audi) is recalling certain 2020-2022 Audi S7, S6 Sedan, A6 Allroad, 2021-2022 RS7, RS6 Avant, 2019-2022 A7, and A6 Sedan vehicles. Liquid spilled in the rear seat may penetrate and cause the gateway control module to shut down.

NHTSANov 21, 2022Nationwide• AUDI

Becton Dickinson & Co.: BBL Chocolate II Agar- IVD for the isolation and cultiva...

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

FDANov 21, 2022Nationwide• Becton Dickinson & Co.

Philips North America Llc: Philips Fetal Spiral Electrode-intended for patients requ...

Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

FDANov 21, 2022Nationwide• Philips North America Llc

Leica Microsystems, Inc.: Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgic...

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Medtronic MiniMed: Guardian iOS app (MMT-8200) and Guardian Android app (MMT...

An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

FDANov 21, 2022Nationwide• Medtronic MiniMed

Leica Microsystems, Inc.: Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premiu...

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Leica Microsystems, Inc.: Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgic...

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

2022 GENUINE SCOOTER BUDDY KICK Recall: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP

Genuine Scooters, LLC is recalling certain 2022 Genuine Buddy Kick 125 motorcycles. The impeller may strike the fuel pump body, causing the fuel pump to fail.

NHTSANov 21, 2022Nationwide• GENUINE SCOOTER

MEDLINE INDUSTRIES, LP Northfield: Medline CISION Sterile Blades. Labeled as follows with c...

Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.

FDANov 18, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

2021 MIDWEST FIRE ALL-POLY SERIES Recall: POWER TRAIN:AUTOMATIC TRANSMISSION

Midwest Fire Equipment & Repair Company (Midwest) is recalling certain 2021-2022 All-Poly Series fire trucks fire trucks equipped with a split-shaft transmission. The Class1 Es-Key multiplex system software may prevent shifting between road-to-pump and pump-to-road modes.

NHTSANov 18, 2022Nationwide• MIDWEST FIRE

2023 UTILIMASTER WALK-IN VAN Recall: SEATS:CRITICAL FASTENERS

Shyft Group is recalling certain 2023 Utilimaster Walk-in vans. The passenger side jump seat may be missing a safety clip that prevents the pivot rod from sliding.

NHTSANov 18, 2022Nationwide• UTILIMASTER

2021 PROTERRA CATALYST Recall: PARKING BRAKE

Proterra Operating Company, Inc. (Proterra) is recalling certain 2020-2021 Catalyst and 2019-2022 ZX5 transit buses. Back pressure in the shared air exhaust for the pneumatic ride height system and parking brake control valve may engage the parking brake while the vehicle is in motion.

NHTSANov 18, 2022Nationwide• PROTERRA

2023 TOYOTA TUNDRA Recall: EQUIPMENT:OTHER:LABELS

Gulf States Toyota, Inc. (GST) is recalling certain 2023 Tundra pickup trucks equipped with non-skid spray-on bed liners. The load carrying capacity modification label may indicate less weight than the actual total weight of accessories installed on the vehicle. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 110, "Tire Selection and Rims."

NHTSANov 18, 2022Nationwide• TOYOTA

2018 COACH AND EQUIPMENT PHOENIX Recall: FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

Coach and Equipment Mfg, Corp. (Coach and Equipment) is recalling certain 2016-2023 Phoenix transit buses equipped with Roush fuel return lines included in GEN 4 and GEN 5 LPG Conversion Systems that were installed on vehicles sold or registered in Connecticut, Delaware, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, Washington D.C., West Virginia, and Wisconsin. The zinc-plating on the fuel return line may break away when contacted by road debris, causing two dissimilar metals on the fuel line to contact each other and corrode.

NHTSANov 18, 2022Nationwide• COACH AND EQUIPMENT

BioReference Health, LLC: The 4Kscore Test is an in vitro serum or plasma test that...

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

FDANov 18, 2022Nationwide• BioReference Health, LLC

ConMed Corporation: Foot Controlled Electrosurgical Suction Coagulator, Elect...

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

FDANov 18, 2022Nationwide• ConMed Corporation

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