Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For... | Product missing the four small locking collar bolts resulting in extension of surgery to find a r... | Class II | Biomet, Inc. |
| Nov 29, 2022 | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Scr... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Nov 28, 2022 | DeRoyal Tonsillectomy Tray, REF 89-10698.01 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot ... | Class II | DeRoyal Industries Inc |
| Nov 23, 2022 | Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA... | Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | LUMINOS Lotus Max (VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and a... | Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 300 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... | The product is labeled with the incorrect expiration date. | Class II | Covidien, LLC |
| Nov 23, 2022 | Luminos Agile Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos dRF Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 22, 2022 | Philips MR 7700 System, Model Number 782120 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality cont... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 22, 2022 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | Reports of an increase in reactive negative controls and false positive results with certain lots... | Class II | Abbott Molecular, Inc. |
| Nov 22, 2022 | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in ... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 22, 2022 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | Reports of an increase in reactive negative controls and false positive results with certain lots... | Class II | Abbott Molecular, Inc. |
| Nov 22, 2022 | Philips Upgrade to MR 7700 System, Model Number 782130 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 21, 2022 | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... | Class II | Leica Microsystems, Inc. |
| Nov 21, 2022 | BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria sp... | Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide e... | Class II | Becton Dickinson & Co. |
| Nov 21, 2022 | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ... | An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom... | Class II | Medtronic MiniMed |
| Nov 21, 2022 | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standa... | There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... | Class II | Leica Microsystems, Inc. |
| Nov 21, 2022 | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... | Class II | Philips North America Llc |
| Nov 21, 2022 | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... | Class II | Leica Microsystems, Inc. |
| Nov 18, 2022 | The 4Kscore Test is an in vitro serum or plasma test that combines the result... | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results | Class II | BioReference Health, LLC |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT- Intended for IV access device ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 0770... | Internal comparison studies revealed unacceptable, light staining. Light staining affects the bo... | Class II | Ventana Medical Systems, Inc. |
| Nov 18, 2022 | Medline CISION Sterile Blades. Labeled as follows with corresponding Item Nu... | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2022 | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction C... | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected d... | Class II | ConMed Corporation |
| Nov 18, 2022 | The Natus Cranial Access Kit is designed to be a complete, single use and dis... | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra... | Class II | Natus Medical Incorporated |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnost... | Beckman Coulter has become aware of an increase in customer complaints generated for intermittent... | Class II | Beckman Coulter, Inc. |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | The firm has received complaints of the device becoming hot. The firm has updated the user manual... | Class II | DeVilbiss Healthcare LLC |
| Nov 18, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... | Class II | Mobius Imaging, LLC |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.