Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 5, 2024 | GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography s... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed t... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tom... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/comput... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/comp... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | NOA Medical Industries Behavioral Health Hospital bed side rails, Product num... | Red button used to engage side rails can break or become stuck making it difficult to engage the ... | Class II | NOA Medical Industries Inc |
| Nov 5, 2024 | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomogra... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomogra... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 4, 2024 | Achieva TX Interventional Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Diagnostic Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Interventional Coil 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | ST SENSE Breast Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 16ch 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Nigh... | Virtual-only clinical workflow utilized for dental aligners and impression to approve patients fo... | Class II | Straight Smile, LLC |
| Nov 4, 2024 | dS Breast 7ch 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | SENSE Breast Coil 3.0T 7ch | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | SENSE Breast Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | ST SENSE Breast Dx Coil | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 7ch 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Atellica CI Analyzer. Catalog Numbers: 10947347. | Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on th... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 4, 2024 | Mammotrak Diagnostic Coil 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | Mammotrak Interventional Coil 3.0T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 4, 2024 | dS Breast 16ch 1.5T | Potential safety issue where a patient may be harmed while preparing for or during a scan. | Class II | Philips North America Llc |
| Nov 1, 2024 | Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Nov 1, 2024 | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA ins... | The DNA fragments for this specific lot number are too large, resulting in potential background a... | Class II | Kreatech Biotechnology Bv |
| Nov 1, 2024 | FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... | Class II | Cardinal Health 200, LLC |
| Nov 1, 2024 | Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... | Class II | Cardinal Health 200, LLC |
| Nov 1, 2024 | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Nov 1, 2024 | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjuncti... | Certain software versions will not notify end users of calls initiated by call points with the Ar... | Class II | Securitas Healthcare LLC |
| Oct 31, 2024 | Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, ste... | Specific lots of product have been manufactured with nonconforming raw materials resulting in the... | Class II | Wilson-Cook Medical Inc. |
| Oct 31, 2024 | BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catal... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Data Management System Version or Model: 440887 Catalog Number... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endo... | Class II | Olympus Corporation of the Americas |
| Oct 31, 2024 | BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | BD EpiCenter Data Management System, Multi User Software Version or Model: 4... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
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.