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.

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DateProductReasonClassFirm
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model PURE 5000/10000. 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 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrumen... Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SA... Class II Nuclein 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 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, Y-... Potential for external cassette leaks Class II Fresenius Kabi USA, LLC
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 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
Jun 23, 2025 BD COR System Software. Model Number: 444829. Potential for functionality issue that supports the Over labeling feature and could lead to poss... Class II Becton Dickinson & Co.
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 20, 2025 GE Signa Artist, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Signa Voyager, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, 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.