Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 27, 2018	Aisys Anesthesia System. Sold under the following product names: AISYS, AIS...	Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath...	Class II	GE Healthcare, LLC
Sep 25, 2018	Panda Wall Mount warmer. Infant radiant warmer	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 25, 2018	Panda iRes Infant Radiant Warmer. Device sold under the following product nam...	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 25, 2018	Giraffe Warmer. Device sold under the following product names: Giraffe Warmer...	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 25, 2018	Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the follow...	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 25, 2018	Panda Freestanding Warmer. Device sold under the following product names: Pa...	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 25, 2018	Giraffe Incubator Carestation. Neonatal incubator. Device sold under the fol...	Potential electric leakage affecting the user.	Class II	GE Healthcare, LLC
Sep 14, 2018	GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended f...	There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) p...	Class II	GE Healthcare, LLC
Sep 14, 2018	GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH A...	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 14, 2018	GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Ca...	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 14, 2018	GE Healthcare Millennium MC	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 11, 2018	B105/125 Patient Monitor. The device is a portable multiparameter unit to ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 10, 2018	DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision ...	Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion ...	Class II	GE Healthcare Biosciences
Sep 4, 2018	GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA...	When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network...	Class II	GE Healthcare Finland Oy
Sep 4, 2018	GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE...	When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network...	Class II	GE Healthcare Finland Oy
Aug 31, 2018	Solar 8000i Patient Monitoring System is used to monitor physiologic paramet...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 4000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 3000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Solar 8000M Patient Monitoring System is used to monitor physiologic paramet...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Solar 9500 Information Monitoring System is used to monitor physiologic para...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 5000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 30, 2018	Centricity Universal Viewer with Cross Enterprise Display This impacts produc...	Remote comparison studies displayed may be associated with the wrong patient, without a caution i...	Class II	GE Healthcare, LLC
Jul 12, 2018	Revolution CT systems with the SmartStep Option The system is intended for...	On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on imag...	Class II	GE Healthcare, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the foll...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 12.x, sold under the following pr...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
Jun 7, 2018	GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr...	The latest on-site software version may not have been reinstalled at some sites after service act...	Class II	GE Medical Systems, LLC
May 25, 2018	GE Healthcare CARESCAPE Monitor B650	When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overlo...	Class II	GE Healthcare Finland Oy
May 24, 2018	Discovery NM/CT 670 ES, model 5376204-70-57	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	CT Goldseal BrightSpeed 16 PWR TIO 2 YR	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery RT labeled as: a. MID BJG; b. HVY BJG	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4...	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery NM/CT 670 Pro, model 5376204-70-54	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	Revolution CT 160 1.5D STD WAUK	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Optima CT 540	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Optima CT 520	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, l...	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery MI Digital Ready	DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be ...	Class II	GE Healthcare, LLC
May 24, 2018	Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ...	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	CT Goldseal Optima CT 600	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
Apr 27, 2018	GE Healthcare Optima CT540. The systems are intended for head, whole body, c...	GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC...	Class II	GE Healthcare Japan Corporation
Apr 27, 2018	GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The ...	GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC...	Class II	GE Healthcare Japan Corporation
Apr 27, 2018	GE Healthcare Optima CT660. Sold under the following product names: BEI...	GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC...	Class II	GE Healthcare Japan Corporation
Apr 27, 2018	GE Healthcare Optima CT660. The systems are intended for head, whole body, c...	GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC...	Class II	GE Healthcare Japan Corporation
Mar 16, 2018	GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, ...	Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de...	Class II	GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018	GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model...	Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de...	Class II	GE Medical Systems Ultrasound & Primary Care Di...

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.