Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 922 FDA device recalls in WI.

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DateProductReasonClassFirm
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 860, SPECT/CT Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery 670 DR Model # H3100BT Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM 830 Model # H3910AC Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 870 CZT Model # H3906CW Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 870 DR Model # H3100AS Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery NM670 Pro Model # H3100XB Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 Discovery NM 630 Model # H3101RH Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 14, 2020 NM/CT 850 Model Number: H3907AD Rotor bearing screws were found loose on detector. Class II GE Healthcare, LLC
Aug 6, 2020 Merge PACS Measurements done on the Merge PACS generated MPR s may have incorrect measurements. Class II Merge Healthcare, Inc.
Jul 14, 2020 CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocesso... The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an ... Class II GE Healthcare, LLC
Jul 6, 2020 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class II Gentueri Inc
Jun 22, 2020 CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi... CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if ... Class II GE Healthcare, LLC
Jun 18, 2020 Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rub... Class II Mueller Sports Medicine, Inc
May 18, 2020 CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCA... The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/... Class II GE Healthcare, LLC
May 8, 2020 Merge Healthcare Merge Application Server Software Release and Merge Healthca... An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... Class II Merge Healthcare, Inc.
Apr 28, 2020 Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... Class II GE Healthcare, LLC
Apr 28, 2020 Giraffe Incubator with installed Servo Oxygen module. Infant incubator. Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... Class II GE Healthcare, LLC
Apr 2, 2020 Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GT... During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) prod... Class II GE Healthcare, LLC
Mar 18, 2020 H12+ and patient cable for the H12+ Holter Recorders with the following devic... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 S4 and patient cable for the S4 Wireless Telemeter with the following device ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 ELI PC. The ELI PC Service automatically converts resting ECG recordings coll... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabil... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 T12. Incorporates wireless electrocardiographic technology to achieve the rea... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 Lead diagnostic electrocardiograph under the following device names: ELI 10, ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 18, 2020 X12+ and patient cable for the X12+ Telemeter with the following device name:... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Dec 23, 2019 SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 23, 2019 SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 23, 2019 SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 23, 2019 SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 16, 2019 Centricity Universal Viewer 6.0, a device that displays medical images and da... Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are inco... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Nov 25, 2019 Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended... GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... Class I GE Healthcare, LLC
Nov 25, 2019 Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended... GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... Class I GE Healthcare, LLC
Nov 12, 2019 CARESCAPE Central Station - Product Usage: The intended use is to provide cli... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Nov 12, 2019 CIC Pro Clinical Information Center Central Station - Product Usage: The inte... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Nov 12, 2019 ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is int... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Oct 11, 2019 Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe Omn... Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe Incubator infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe OmniBed infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCOVX Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCAiOE Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.