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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 381–400 of 1,000 recalls

Class IIITerminated

SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve.

Advanced Bionics, LLC

The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.

April 4, 2019 · DeviceView details →

Class IIITerminated

cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Roche Diagnostics Corporation

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

April 4, 2019 · DeviceView details →

Class IIITerminated

cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

Roche Diagnostics Corporation

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

April 4, 2019 · DeviceView details →

Class IIITerminated

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Fresenius Medical Care Renal Therapies Group, LLC

Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

April 3, 2019 · DeviceView details →

Class IIITerminated

Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.

GETINGE US SALES LLC

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

March 20, 2019 · DeviceView details →

Class IIITerminated

BIOPHEN UFH Control C1, REF 224101

Aniara Diagnostica LLC

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

March 19, 2019 · DeviceView details →

Class IIITerminated

BIOPHEN LMWH Control C4, REF 224201

Aniara Diagnostica LLC

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

March 19, 2019 · DeviceView details →

Class IIITerminated

BIOPHEN UFH Control C2, REF 223901

Aniara Diagnostica LLC

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

March 19, 2019 · DeviceView details →

Class IIITerminated

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

Advanced Bionics, LLC

Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

March 18, 2019 · DeviceView details →

Class IIITerminated

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Cytocell Ltd.

There is an error in the chromomap included in the labeling for the product.

March 15, 2019 · DeviceView details →

Class IIIOngoing

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

March 4, 2019 · DeviceView details →

Class IIITerminated

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

Teleflex Medical

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

February 27, 2019 · DeviceView details →

Class IIITerminated

McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30

Cypress Medical Products LLC

Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

February 27, 2019 · DeviceView details →

Class IIITerminated

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

Teleflex Medical

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

February 27, 2019 · DeviceView details →

Class IIITerminated

Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

Updates to the Instructions for Use.

February 25, 2019 · DeviceView details →

Class IIITerminated

Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

Updates to the Instructions for Use.

February 25, 2019 · DeviceView details →

Class IIITerminated

Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:(1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

Updates to the Instructions for Use.

February 25, 2019 · DeviceView details →

Class IIITerminated

NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

Nidek, Inc.

The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

February 25, 2019 · DeviceView details →

Class IIITerminated

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated;(2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

Updates to the Instructions for Use.

February 25, 2019 · DeviceView details →

Class IIITerminated

Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

Updates to the Instructions for Use.

February 25, 2019 · DeviceView details →

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