Browse Device Recalls

918 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 918 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 918 FDA device recalls in WI.

Clear
DateProductReasonClassFirm
Feb 18, 2025 GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Jan 28, 2025 Discovery XR656HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Jan 28, 2025 Discovery XR656 HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Jan 28, 2025 Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00... The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Jan 28, 2025 Optima XR646 HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Dec 23, 2024 CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System ma... Snap rings may become partially or completed detached from the shafts within the internal mechani... Class II Accuray Incorporated
Dec 6, 2024 Portrait Core Services, a set of software services that enable the communicat... There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-0... Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 11, 2024 TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) An out of specification component may result in the device exhibiting torque output higher than t... Class II Gauthier Biomedical, Inc.
Oct 28, 2024 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 SIGNA Architect, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 Discovery MR750w 3.0T, whole body magnetic resonance scanner Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 3, 2024 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Sep 3, 2024 GE Heathcare Giraffe OmniBed; neo natal incubator GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Jul 12, 2024 Aespire View. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 7900. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Amingo. OUS only. Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance. This anesthesia gas machine is intended to provide general inhalation... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. Th... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys. This anesthesia gas machine is intended to provide general inhalation ... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to ... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 100. This anesthesia gas machine is intended to provide general inhal... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jun 14, 2024 Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, 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.