Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 3, 2013	GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage...	GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ...	Class II	GE Healthcare, LLC
Apr 3, 2013	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Health...	GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ...	Class II	GE Healthcare, LLC
Apr 3, 2013	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The int...	GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ...	Class II	GE Healthcare, LLC
Mar 28, 2013	Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic res...	Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.	Class II	GE Healthcare, LLC
Mar 28, 2013	MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic ...	Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.	Class II	GE Healthcare, LLC
Mar 26, 2013	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body ...	GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio...	Class II	GE Healthcare, LLC
Mar 26, 2013	GE, Optima CT660. Intended to produce cross-sectional images of the body b...	GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio...	Class II	GE Healthcare, LLC
Feb 8, 2013	GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ...	GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us...	Class II	GE Healthcare, LLC
Jan 21, 2013	GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Inn...	A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, I...	Class II	GE Healthcare, LLC
Jan 14, 2013	GE Healthcare Senographe Essential System. The Senographe 2000D system gen...	GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instruc...	Class II	GE Healthcare, LLC
Jan 9, 2013	Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models...	GE Healthcare has recently become aware of an incident which caused a patient injury during an un...	Class II	GE Healthcare, LLC
Jan 8, 2013	Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label...	Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ...	Class I	GE Healthcare, LLC
Nov 9, 2012	GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a ...	GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data fr...	Class II	GE Healthcare, LLC
Oct 15, 2012	GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 15, 2012	Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitat...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 12, 2012	GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical too...	GE Healthcare has recently become aware of a potential safety issue associated with the table pa...	Class II	GE Healthcare, LLC
Sep 26, 2012	GE Healthcare Definium 5000/5220493-2 X-Ray System	When quickly switching the protocols from AEC to Fixed under the same view, if the user selection...	Class II	GE Healthcare, LLC
Sep 26, 2012	GE Healthcare Definium 5000 / 5220493 X-Ray System	When quickly switching the protocols from AEC to Fixed under the same view, if the user selection...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183...	GE Healthcare has recently become aware that patient mismatch without a warning message could occ...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of ...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Aug 16, 2012	GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst...	GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21...	Class II	GE Healthcare, LLC
Aug 13, 2012	GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ...	GE Healthcare became aware of a potential issue related to incorrect image measurement associated...	Class II	GE Healthcare, LLC
Aug 7, 2012	GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The s...	GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx,...	Class II	GE Healthcare, LLC
Aug 3, 2012	GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System	GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Mode...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Jul 20, 2012	CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is ...	GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. The...	Class II	GE Healthcare, LLC
Jul 13, 2012	GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. ...	GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an ...	Class II	GE Healthcare, LLC
Jul 12, 2012	GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul...	GE Healthcare has recently become aware of a number of potential issues associated with the CARE...	Class II	GE Healthcare, LLC
Jul 10, 2012	Optima XR200amx. Mobile general purpose radiographic imaging of the human he...	Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects...	Class II	GE Healthcare, LLC
Jul 10, 2012	Optima XR220amx Mobile general purpose radiographic imaging of the human h...	Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects...	Class II	GE Healthcare, LLC
Jun 28, 2012	GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar...	GE Healthcare has recently become aware of a potential safety issue with respect to the Results V...	Class II	GE Healthcare, LLC
Jun 26, 2012	GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monito...	GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom ...	Class II	GE Healthcare, LLC
Jun 26, 2012	GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal...	Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In...	Class I	GE Healthcare, LLC
Jun 13, 2012	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monit...	GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. The...	Class II	GE Healthcare, LLC
Jun 13, 2012	GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking st...	GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor....	Class II	GE Healthcare, LLC
Jun 12, 2012	GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 201...	GE Healthcare has become aware through complaints of a potential safety issue with its Invasive B...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without ...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnos...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR ...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
May 29, 2012	Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a...	GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis...	Class II	GE Healthcare, LLC
May 25, 2012	GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Vie...	Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safe...	Class II	GE Healthcare, LLC
May 24, 2012	GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advanta...	GE Healthcare has become aware of an issue associated with the magnification images acquired on n...	Class II	GE Healthcare, LLC
May 24, 2012	GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4....	GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o...	Class II	GE Healthcare, LLC
May 24, 2012	AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009...	It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t...	Class II	GE Healthcare, LLC
May 24, 2012	GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an...	GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv...	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.