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 |
|---|---|---|---|---|
| May 13, 2025 | Product Name: Ingenia 1.5T S; Model Number: 781347; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Ami HTX. | The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... | Class II | Spectral Instruments Inc |
| May 13, 2025 | Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T CX; Model Number: 781262; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 3.0T CX; Model Number: 781271; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 12, 2025 | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue in... | Class II | Intuitive Surgical, Inc. |
| May 12, 2025 | BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & ST... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-00... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-01... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China)... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | Baxter Novum IQ Syringe Pump, product code 40800BAXUS, | Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... | Class II | Baxter Healthcare Corporation |
| May 12, 2025 | BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, R... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue G... | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole ... | Class II | HemoCue AB |
| May 12, 2025 | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... | Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... | Class I | Fresenius Kabi USA, LLC |
| May 9, 2025 | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K... | Cathode ray tube display system encoders and decoders have same MAC address; new system setup wit... | Class II | Barco N.V. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 9, 2025 | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 9, 2025 | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory suppo... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 9, 2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... | The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... | Class II | Baxter Healthcare Corporation |
| May 8, 2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BL... | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... | Class II | BALT USA, LLC |
| May 8, 2025 | BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400... | Antivirus software was not consistently installed on impacted devices during the implementation p... | Class II | CareFusion 303, Inc. |
| May 8, 2025 | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1... | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... | Class II | BALT USA, LLC |
| May 8, 2025 | Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P... | During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in... | Class II | CareFusion 303, Inc. |
| May 8, 2025 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... | Class II | Ohio Medical Corporation |
| May 7, 2025 | DxI 9000 Access Immunoassay Analyzer C11137 | Analyzer has calibration issues where curves switched from passed to failed due to system errors ... | Class II | Beckman Coulter, Inc. |
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: Valeda Light Delivery System Product Name: Light Based Device fo... | U.S. customers were shipped devices that were configured for the European Union and were unable t... | Class III | LUMITHERA INC |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Ony... | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. | Class II | MicroAire Surgical Instruments, LLC |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000... | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| May 7, 2025 | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... | Class II | Medtronic MiniMed, Inc. |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium ... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | HardyCHROM CRE, selective and differential culture medium for antimicrobial s... | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Kl... | Class II | Hardy Diagnostics |
| May 6, 2025 | Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... | There is a potential for improper crimps on the signal wires of the actuators which could result ... | Class II | Baxter Healthcare Corporation |
| May 6, 2025 | PhenoMATRIX | AI-powered bacterial culture plate interpretation and workup software does not have Premarket App... | Class II | Copan WASP |
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.