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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Date	Product	Reason	Class	Firm
Sep 27, 2019	CARESCAPE Respiratory Module E-sCAiOVE	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-sCAiO	Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ...	Class I	GE Healthcare, LLC
Sep 27, 2019	Airway Gas Option N-CAiO	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-sCAiOV	Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ...	Class I	GE Healthcare, LLC
Sep 16, 2019	CardioLab/ComboLab Recording Systems	Potential for failure of the patient leakage current test. There is a potential that if another d...	Class II	GE Healthcare, LLC
Sep 3, 2019	Achilles Insight Bone Sonometer	Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow...	Class II	GE Healthcare, LLC
Sep 3, 2019	Achilles Express Bone Sonometer	Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow...	Class II	GE Healthcare, LLC
Aug 30, 2019	ApexPro Telemetry Server System. Also identified as Modification To: ApexPro...	May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Informa...	Class II	GE Healthcare, LLC
Aug 27, 2019	AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-9...	The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potent...	Class II	Ad-Tech Medical Instrument Corporation
Aug 9, 2019	Proteus XR/a (SlOK : K993090)	Intermittently not receiving an audible exposure indication upon completion of an exposure on the...	Class II	GE Healthcare, LLC
Jul 26, 2019	Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated a...	Fasteners potentially torqued to a value less than the specified value and can potentially cause ...	Class II	GE Healthcare, LLC
Jul 19, 2019	Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3....	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-91...	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023...	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 19, 2019	Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-...	Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta...	Class II	GE Healthcare, LLC
Jul 11, 2019	Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1	Potential for prior thumbnails to not display in reverse chronological order and images may not s...	Class II	Merge Healthcare, Inc.
Jul 11, 2019	Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1	Potential for prior thumbnails to not display in reverse chronological order and images may not s...	Class II	Merge Healthcare, Inc.
Jul 2, 2019	Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish R...	Potential for a transducer mis-alignment in certain transvaginal probes.	Class II	GE Healthcare, LLC
Jul 2, 2019	Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D	Potential for a transducer mis-alignment in certain transvaginal probes.	Class II	GE Healthcare, LLC
Jun 28, 2019	MAC VU360, Model Number 2030360-001, Electrocardiograph	Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit ...	Class II	GE Healthcare, LLC
Jun 27, 2019	Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-...	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes...	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, RE...	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes...	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 27, 2019	Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syri...	The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bun...	Class II	Inter-Med Llc
Jun 18, 2019	Skull Anchor Bolts	Supplemental information provided with devices may indicate that the subdural electrodes, depth e...	Class II	Ad-Tech Medical Instrument Corporation
Jun 18, 2019	Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode...	Supplemental information provided with devices indicates that the subdural electrodes, depth elec...	Class II	Ad-Tech Medical Instrument Corporation
Jun 18, 2019	LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized ...	On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 a...	Class II	Ad-Tech Medical Instrument Corporation
Jun 18, 2019	Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Elec...	Supplemental information provided with devices indicates that the subdural electrodes, depth elec...	Class II	Ad-Tech Medical Instrument Corporation
Jun 4, 2019	Powerheart¿ G5 Automatic AED	Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determi...	Class II	Cardiac Science Corporation
May 22, 2019	GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 ...	There is a potential that one or more image series (i.e., all images within an image set) may b...	Class II	GE Healthcare, LLC
May 21, 2019	LVivo EF app on Vscan Extend. Sold under the following product names: a...	Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo E...	Class II	GE Healthcare, LLC
May 17, 2019	Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255...	There is a potential that one or more images or image series may be missing from exams without a ...	Class II	GE Healthcare, LLC
May 17, 2019	Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-00...	There is a potential that one or more images or image series may be missing from exams without a ...	Class II	GE Healthcare, LLC
May 16, 2019	Centricity PACS Foundation Centricity PACS software product is intended fo...	There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco...	Class II	GE Healthcare, LLC
May 16, 2019	GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory ...	Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.	Class II	GE Healthcare, LLC
May 16, 2019	GE Senographe Pristina - Product Usage: Senographe Pristina generates digital...	Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.	Class II	GE Healthcare, LLC
May 16, 2019	Centricity Universal Viewer 6.0 Is a device that displays medical images a...	There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco...	Class II	GE Healthcare, LLC
May 10, 2019	ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	Replacement ECG leadwires with snap ends REF/Catalog Number Description 210...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	Replacement leadwires with grabber ends: REF/Catalog Number Description 210...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
Apr 16, 2019	AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El...	An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en...	Class II	Ad-Tech Medical Instrument Corporation
Mar 29, 2019	Precision 500D The Precision 500D R&F X-ray System is intended to be used...	There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m...	Class II	GE Healthcare, LLC
Mar 29, 2019	Proteus XR/a The Proteus XR/a radiographic system offers the flexibility ...	There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m...	Class II	GE Healthcare, LLC
Mar 29, 2019	Silhouette VR This fully integrated system offers intuitive controls with...	There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m...	Class II	GE Healthcare, LLC
Mar 29, 2019	Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purp...	There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m...	Class II	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.