Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 30, 2025 | Intera 3.0T Quasar Dual Model Number (REF): 781150; | 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 | Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; | 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 | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The Hea... | Due to a component manufacturing issue, Automated External Defibrillator may not function properl... | Class II | HeartSine Technologies Ltd |
| Jun 30, 2025 | Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD... | Potential for temporary loss of imaging (X-ray) functionality due to software issue. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 30, 2025 | Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; | 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 | DreamStation Auto CPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | DreamStation Auto. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto BiPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| 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 | Ingenia 1.5T S Model Number (REF): 781347; | 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 3.0T Model Number (REF): 782145; | 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 Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (... | 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 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics Inc |
| Jun 27, 2025 | Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg... | Device does not comply with the labeling requirements of international standard IEC 60601-1. | Class II | Maquet Cardiopulmonary Gmbh |
| Jun 27, 2025 | Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working leng... | Affected product show elevated cytotoxicity values. Use of affected injection needles may present... | Class II | Spiggle & Theis Mt Gmbh |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics Inc |
| Jun 26, 2025 | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation ... | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas ... | Class II | bioMerieux, Inc. |
| Jun 26, 2025 | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve... | Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fr... | Class I | Hamilton Medical AG |
| Jun 26, 2025 | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot W... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 26, 2025 | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting... | Class II | Beckman Coulter Inc. |
| Jun 25, 2025 | MicroScan Neg MIC 3J REF C54814 | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibi... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 | Engaging titanium base was manufactured 180 degrees around the post from where it should be locat... | Class II | Preat Corp |
| Jun 25, 2025 | DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combinati... | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Pot... | Class II | Nuclein LLC |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 | The potentially impacted units were manufactured using specific equipment that may have caused cr... | Class II | Boston Scientific Corporation |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 24, 2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 90... | Due to manufacturing error, digital analog rotational feature is 180 degrees off. | Class II | Preat Corp |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-37... | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect... | Class II | Orthofix U.S. LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 23, 2025 | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 1000594... | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay... | Class II | Covidien |
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.