Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 6, 2024 | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used ... | 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) LAMINECTOM... | 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 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 | 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 | 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 | 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 | 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 | FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various... | 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) CRANIOTOMY,... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascu... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for v... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | KIT,SPINE LH Convenience kit, SKU DYNJ906448A. | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovas... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular 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 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 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 | 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 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 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 |
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.