Browse Device Recalls
39,162 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,162 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 39,162 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2026 | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing... | Sterile wound dressing, lacks sterility assurance | Class II | DeRoyal Industries Inc |
| May 13, 2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 13, 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 6, 2026 | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typica... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA.... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of th... | It has been identified that the impacted docking station (SN 2521008873) was not product released... | Class II | Stryker Corporation |
| May 6, 2026 | Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 4, 2026 | Pediatric care bed; Product Designation: KayserBett IDA; | If the adjustment functions of the hand control, as instructed in the Manual, are not locked with... | Class I | KAYSERBETTEN GMBH & CO. KG |
| Apr 30, 2026 | BD Pyxis MedStation ES Tower REF: 352 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation ES REF: 323 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... | Due to incorrect shelf-life expiration date. | Class II | Advanced Bionics, LLC |
| Apr 30, 2026 | BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis Mini Main REF: 349 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 30, 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Integris-Allura system; System Code Description (Model Numbers): Integris CV ... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Philips Azurion systems not configured with an optional auxiliary pan handle.... | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table move... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 27, 2026 | Aligned Medical AMS16835 Fluids Kit RX | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was ... | Class II | Windstone Medical Packaging, Inc. |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer... | Class II | Oculus Technologies of Mexico, S.A. de C.V. |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 24, 2026 | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer b... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... | Class II | Intuitive Surgical, Inc. |
| Apr 24, 2026 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) us... | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on... | Class II | Bayer Medical Care, Inc. |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Prod... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... | Class II | Devicor Medical Products Inc |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 23, 2026 | Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the foll... | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or c... | Class II | Kico Knee Innovation Company |
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.