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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 4621–4640 of 39,430 recalls

Class IIOngoing

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT

GE Healthcare (China) Co., Ltd.

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

November 5, 2024 · DeviceView details →
Class IIOngoing

Microscissor Tip (Disposable); Microline Catalog #: 3122.

Microline Surgical, Inc.

A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.

November 5, 2024 · DeviceView details →
Class IIOngoing

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

November 5, 2024 · DeviceView details →
Class IIOngoing

dS Breast 16ch 1.5T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Mammotrak Interventional Coil 3.0T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Mammotrak Diagnostic Coil 1.5T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Atellica CI Analyzer. Catalog Numbers: 10947347.

Siemens Healthcare Diagnostics, Inc.

Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.

November 4, 2024 · DeviceView details →
Class IIOngoing

dS Breast 7ch 3.0T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

ST SENSE Breast Dx Coil

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

SENSE Breast Coil

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

SENSE Breast Coil 3.0T 7ch

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

dS Breast 7ch 1.5T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.

Straight Smile, LLC

Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.

November 4, 2024 · DeviceView details →
Class IIOngoing

dS Breast 16ch 3.0T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

ST SENSE Breast Coil

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Mammotrak Interventional Coil 1.5T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Mammotrak Diagnostic Coil 3.0T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Achieva TX Interventional Coil 3.0T

Philips North America Llc

Potential safety issue where a patient may be harmed while preparing for or during a scan.

November 4, 2024 · DeviceView details →
Class IIOngoing

Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application

Securitas Healthcare LLC

Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

November 1, 2024 · DeviceView details →
Class IOngoing

Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).

Medtronic Neurosurgery

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

November 1, 2024 · DeviceView details →
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