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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 921–940 of 1,000 recalls

Class IIOngoing

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Merit Medical Systems, Inc.

Inflation device handle may detach from the syringe during procedure.

December 4, 2025 · DeviceView details →

Class IIOngoing

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

Merit Medical Systems, Inc.

Inflation device handle may detach from the syringe during procedure.

December 4, 2025 · DeviceView details →

Class IIOngoing

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

Mobius Imaging, LLC

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

December 4, 2025 · DeviceView details →

Class IIOngoing

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

Merit Medical Systems, Inc.

Inflation device handle may detach from the syringe during procedure.

December 4, 2025 · DeviceView details →

Class IIOngoing

Allwell Angioplasty Pack REF: IS-30-B1/B

Merit Medical Systems, Inc.

Inflation device handle may detach from the syringe during procedure.

December 4, 2025 · DeviceView details →

Class IIOngoing

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

Medtronic Inc

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

December 4, 2025 · DeviceView details →

Class IIOngoing

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Abiomed, Inc.

Device packaged in incorrect outer box carton.

December 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A

Intuitive Surgical, Inc.

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

December 4, 2025 · DeviceView details →

Class IIOngoing

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

Potential for incomplete scan due to unstable connection inside of floating sensor.

December 3, 2025 · DeviceView details →

Class IIOngoing

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.

CareFusion 303, Inc.

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

December 3, 2025 · DeviceView details →

Class IIOngoing

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

Medtronic Neuromodulation

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

December 3, 2025 · DeviceView details →

Class IIOngoing

Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

Class IIOngoing

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

Philips North America

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

December 3, 2025 · DeviceView details →

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