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 |
|---|---|---|---|---|
| Jul 14, 2025 | Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001... | Under certain conditions, such as the simultaneous use of the operating table with other medical ... | Class II | MAQUET GMBH |
| Jul 11, 2025 | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood/MacConkey Biplate 100/PK, Product Number R02049 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Strep Selective II Agar, Product Number R01859 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal f... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAI... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jul 11, 2025 | Blood/EMB, Levine 100/PK, Product Number R02041 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED,... | Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... | Class II | Onkos Surgical, Inc. |
| Jul 10, 2025 | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Ca... | Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely in... | Class II | Beckman Coulter, Inc. |
| Jul 10, 2025 | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nuc... | FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures w... | Class II | Biofire Defense |
| Jul 9, 2025 | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 9, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Encore Medical, LP |
| Jul 9, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Encore Medical, LP |
| Jul 8, 2025 | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 8, 2025 | The Medline General Surgery Tray is customized to meet requirements of the ho... | Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb... | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, ... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 340335 | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 7, 2025 | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some e... | Class II | Siemens Healthcare Diagnostics Inc |
| Jul 3, 2025 | Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a scr... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad ... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... | an app defect that occurs when the phone is set to a right-to-left language, which causes app-pu... | Class II | Tandem Diabetes Care, Inc. |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes configured with Phantom Frames | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes with Dragonfly frames | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pa... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 2, 2025 | Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-32... | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error messa... | Class II | Spark Biomedical Inc |
| Jul 2, 2025 | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1B... | Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure,... | Class II | Stryker Corporation |
| Jul 2, 2025 | GE HealthCare OEC 9800. | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... | Class II | GE Medical Systems, LLC |
| Jul 2, 2025 | GE HealthCare OEC 9900 Elite C-arm Systems. | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... | Class II | GE Medical Systems, LLC |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside ... | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potentia... | Class II | North American Rescue LLC. |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jun 30, 2025 | MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. | The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... | Class II | Beyond Laser Systems, LLC |
| Jun 30, 2025 | Upgrade to MR 7700 Model Number (REF): 782130; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | SPINEART SA |
| Jun 30, 2025 | Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000. | The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... | Class II | Beyond Laser Systems, LLC |
| Jun 30, 2025 | Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
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.