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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 641–660 of 1,000 recalls

Class ITerminated

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

There is a potential for false positive results.

September 2, 2021 · DeviceView details →

Class IITerminated

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

Medtronic Sofamor Danek USA Inc

Engraving on implants may not match what is listed on the pouch labels.

September 2, 2021 · DeviceView details →

Class IITerminated

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Medtronic Sofamor Danek USA Inc

Engraving on implants may not match what is listed on the pouch labels.

September 2, 2021 · DeviceView details →

Class IITerminated

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

BioMerieux SA

Under certain conditions, there is a risk for a false negative result.

September 2, 2021 · DeviceView details →

Class ITerminated

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

There is a potential for false positive results.

September 2, 2021 · DeviceView details →

Class ITerminated

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

There is a potential for false positive results.

September 2, 2021 · DeviceView details →

Class ITerminated

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

There is a potential for false positive results.

September 2, 2021 · DeviceView details →

Class ITerminated

Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

There is a potential for false positive results.

September 2, 2021 · DeviceView details →

Class ITerminated

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Deroyal Industries, Inc. Lafollette

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

September 2, 2021 · DeviceView details →

Class IITerminated

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Thoraguard Chest Tube Kit, 20 Fr

Centese Inc.

An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

August 31, 2021 · DeviceView details →

Class IITerminated

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

Class IITerminated

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

Class IITerminated

SOMATOM Force with software syngo.CT VB20 Model #10742326

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

Class IITerminated

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

Class IITerminated

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

Class IITerminated

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →

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