Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 6, 2024 | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in c... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN... | Due to a data migration from on-premises server to the cloud environment, some customers reported... | Class II | St. Jude Medical |
| Nov 6, 2024 | ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... | Due to finished goods incorrectly packaged and labeled. | Class II | ICU Medical, Inc. |
| Nov 6, 2024 | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular p... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 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 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 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 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 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 Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... | 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 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 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 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 | 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 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 | 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 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 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 | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta N... | Due to potential system error alarm and the inability to initiate therapy as a result of broken o... | Class II | KCI USA, INC. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... | 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 | Microscissor Tip (Disposable); Microline Catalog #: 3122. | A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink break... | Class II | Microline Surgical, Inc. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 | 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 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 | 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 |
| 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 | 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 | 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 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 | 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 | 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 | 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 |
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.