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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 681–700 of 1,000 recalls

Class IITerminated

Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD

Elekta, Inc.

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

September 17, 2021 · DeviceView details →

Class IITerminated

The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

Bayer Medical Care, Inc.

Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)

September 14, 2021 · Device

View details →

Class IITerminated

ARCH Leg Positioning System

Innovative Orthopedic Technologies, LLC

Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

September 13, 2021 · DeviceView details →

Class IITerminated

Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

Kinsman Enterprises Inc

The belt may fail at lower loads than the labeled 600lbs.

September 10, 2021 · DeviceView details →

Class IITerminated

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966

Ortho Clinical Diagnostics Inc

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

September 10, 2021 · DeviceView details →

Class IITerminated

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

DePuy Orthopaedics, Inc.

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

September 9, 2021 · DeviceView details →

Class IITerminated

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

RAYSEARCH LABORATORIES AB

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

September 9, 2021 · DeviceView details →

Class IITerminated

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

K2M, Inc

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

September 8, 2021 · DeviceView details →

Class IITerminated

Kit: Central Line Dres Change 20/Cs

Medical Action Industries, Inc. 306

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

September 8, 2021 · DeviceView details →

Class IITerminated

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

NOX MEDICAL

Error in the device firmware results in the inaccurate detection of device position.

September 7, 2021 · DeviceView details →

Class IITerminated

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Flower Orthopedics Corporation

Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

September 3, 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 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 →

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