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
Dec 29, 2023	EVair air compressor, model numbers: M1230849 and M1230847	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Dec 29, 2023	EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230...	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Dec 29, 2023	EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun...	Class I	Datex-Ohmeda, Inc.
Dec 26, 2023	GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 22, 2023	GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ul...	GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Pr...	Class II	GE HEALTHCARE AUSTRIA GMBH & CO
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 1, 2023	Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c...	Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share...	Class II	CHANGE HEALTHCARE CANADA COMPANY
Oct 12, 2023	Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2...	Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14....	Class II	CHANGE HEALTHCARE CANADA COMPANY
Sep 14, 2023	Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica...	GE HealthCare has become aware of an issue where images from two different patients may be contai...	Class II	GE Healthcare
Sep 14, 2023	Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad...	GE HealthCare has become aware of an issue where images from two different patients may be contai...	Class II	GE Healthcare
Sep 14, 2023	Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found...	GE HealthCare has become aware of an issue where images from two different patients may be contai...	Class II	GE Healthcare
Sep 8, 2023	Centricity Universal Viewer Workflow Manager, Image processing radiological s...	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir...	Class II	GE Healthcare
Sep 8, 2023	Universal Viewer Workflow Manager, Image processing radiological system	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir...	Class II	GE Healthcare
Jun 6, 2023	GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator a...	Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo...	Class I	DATEX--OHMEDA, INC.
Jun 6, 2023	GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb...	Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo...	Class I	DATEX--OHMEDA, INC.
May 30, 2023	GE Healthcare Vivid S60, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	GE Healthcare Vivid S70, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	GE Healthcare Vivid S70N, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 30, 2023	GE Healthcare Vivid S60N, ultrasound device	GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f...	Class II	GE Vingmed Ultrasound As
May 19, 2023	TruSignal Ear Sensor, REF TS-E-D; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-9...	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
May 19, 2023	TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Wrap Sensor, REF TS-W-D; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	Beside panel FRU (Field Replacement Units) Kits	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
May 19, 2023	TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 20...	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could h...	Class II	DATEX--OHMEDA, INC.
May 19, 2023	TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ...	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
May 19, 2023	TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter	There is a potential reduction of energy reaching patient during defibrillation, potential contac...	Class I	GE Healthcare Finland Oy
Mar 28, 2023	Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2...	GE HealthCare has become aware of an issue where information from two different patients can be m...	Class II	GE Healthcare
Mar 28, 2023	Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog ...	GE HealthCare has become aware of an issue where information from two different patients can be m...	Class II	GE Healthcare
Mar 28, 2023	Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-...	GE HealthCare has become aware of an issue where information from two different patients can be m...	Class II	GE Healthcare
Nov 16, 2022	B125M Patient Monitor, REF 6160000-005-XXXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105M Patient Monitor, REF 6160000-003	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B125P Patient Monitor (with E-module slot option), REF 6160000-002	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B125M Patient Monitor, REF 6160000-004-XXXXXX	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Nov 16, 2022	B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"...	Class II	GE Medical Systems, LLC
Oct 28, 2022	Centricity PACS-IW with Universal Viewer version 5.0. Used to display me...	There is the potential that after installation of the IAS tool, some studies can remain hidden wi...	Class II	GE Medical Systems, LLC
Oct 28, 2022	Centricity Universal Viewer 6.0. Used to display medical images (Includi...	There is the potential that after installation of the IAS tool, some studies can remain hidden wi...	Class II	GE Medical Systems, LLC
Jul 15, 2022	(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity ...	Inaccurate Distance and Area measurements with use of Global Stack viewport.	Class II	GE Healthcare, LLC
Jun 24, 2022	SIGNA Premier magnetic resonance scanner, model 5748519.	Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise durin...	Class II	GE Healthcare, LLC
Jun 14, 2022	Centricity PACS Software Version 7.0 SP0.0.4.7	The Event Notification Manager (ENM) functionality for certain products does not process notifica...	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.