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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 901–920 of 1,000 recalls

Class IOngoing

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Boston Scientific Corporation

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

December 19, 2025 · DeviceView details →
Class IIOngoing

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

ICU Medical Inc.

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

December 19, 2025 · DeviceView details →
Class IIOngoing

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

Canon Medical System, USA, INC.

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

December 19, 2025 · DeviceView details →
Class IIOngoing

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Altruan GmbH

Product not cleared by the FDA.

December 19, 2025 · DeviceView details →
Class IIOngoing

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Tornier, Inc

A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

December 19, 2025 · DeviceView details →
Class IIOngoing

Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE

MicroPort Orthopedics Inc.

Due to products not having FDA Premarket authorization to be distributed within the United States.

December 19, 2025 · DeviceView details →
Class IIOngoing

Portex Spinal Tray, Item No. A3729-24 A3595

ICU Medical Inc.

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

December 19, 2025 · DeviceView details →
Class IIOngoing

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Siemens Medical Solutions USA, Inc

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

December 19, 2025 · DeviceView details →
Class IIOngoing

Alphenix INFX-8000H, interventional fluoroscopic x-ray system

Canon Medical System, USA, INC.

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

December 19, 2025 · DeviceView details →
Class IOngoing

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Boston Scientific Corporation

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

December 19, 2025 · DeviceView details →
Class IIOngoing

Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Canon Medical System, USA, INC.

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

December 19, 2025 · DeviceView details →
Class IOngoing

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Boston Scientific Corporation

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

December 19, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Altruan GmbH

Product not cleared by the FDA.

December 19, 2025 · DeviceView details →
Class IIOngoing

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm

Tyber Medical

The supplier manufactured anatomical left plates with an incorrect thread orientation.

December 19, 2025 · DeviceView details →
Class IIOngoing

Alphenix INFX-8000C, interventional fluoroscopic x-ray system

Canon Medical System, USA, INC.

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

December 19, 2025 · DeviceView details →
Class IIOngoing

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Siemens Medical Solutions USA, Inc

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

December 19, 2025 · DeviceView details →
Class IIOngoing

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Altruan GmbH

Product not cleared by the FDA.

December 19, 2025 · DeviceView details →
Class IIOngoing

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

Wilson-Cook Medical Inc.

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

December 18, 2025 · DeviceView details →
Class IIOngoing

Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.

Community Products, LLC

Potential for fraying on the body support strap.

December 18, 2025 · DeviceView details →
Class IIOngoing

Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.

Community Products, LLC

Potential for fraying on the body support strap.

December 18, 2025 · DeviceView details →
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