Browse Device Recalls
983 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 983 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 983 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 2, 2024 | GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... | Class II | GE Vingmed Ultrasound As |
| Apr 9, 2024 | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON... | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | Class II | GE Medical Systems Information Technologies Inc |
| Apr 5, 2024 | CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 5, computed tomography x-ray system | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| 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 |
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.