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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 781–800 of 1,000 recalls

Class IITerminated

MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

CAREFUSION

A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.

June 9, 2021 · DeviceView details →

Class IITerminated

728333 Spectral CT 7500 -Computed Tomography X-ray system

Philips North America Llc

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

June 8, 2021 · DeviceView details →

Class IITerminated

728332 IQon Spectral CT-Computed Tomography X-ray system

Philips North America Llc

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

June 8, 2021 · DeviceView details →

Class IITerminated

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Philips North America Llc

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

June 8, 2021 · DeviceView details →

Class IITerminated

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Philips North America Llc

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

June 8, 2021 · DeviceView details →

Class IITerminated

RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;

RAYSEARCH LABORATORIES AB

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

June 8, 2021 · DeviceView details →

Class IITerminated

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Terumo Cardiovascular Systems Corporation

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

June 8, 2021 · DeviceView details →

Class IITerminated

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Philips North America Llc

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

June 8, 2021 · DeviceView details →

Class IITerminated

reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.

June 7, 2021 · DeviceView details →

Class IITerminated

reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.

June 7, 2021 · DeviceView details →

Class IITerminated

FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

BioFire Diagnostics, LLC

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

June 7, 2021 · DeviceView details →

Class IITerminated

FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

BioFire Diagnostics, LLC

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

June 7, 2021 · DeviceView details →

Class IITerminated

Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

June 4, 2021 · DeviceView details →

Class IITerminated

Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

June 4, 2021 · DeviceView details →

Class IITerminated

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Axonics Modulation Technologies, Inc.

Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized

June 3, 2021 · DeviceView details →

Class IITerminated

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A

Ethicon Endo-Surgery Inc

Mislabeled: Labeled on the package as 60mm contains 45mm devices

June 3, 2021 · DeviceView details →

Class IITerminated

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301

Biomet, Inc.

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

June 2, 2021 · DeviceView details →

Class IITerminated

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Biomet, Inc.

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

June 2, 2021 · DeviceView details →

Class IITerminated

Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343

Biomet, Inc.

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

June 2, 2021 · DeviceView details →

Class IITerminated

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314

Biomet, Inc.

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

June 2, 2021 · DeviceView details →

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