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 |
|---|---|---|---|---|
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm... | There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... | Class II | Augustine Temperature Management, LLC |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 c... | There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... | Class II | Augustine Temperature Management, LLC |
| Dec 16, 2024 | Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-... | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 15, 2024 | Calibrate CCX Interbody System for spinal fusion procedures: Implants: ... | Complaints have been received regarding post-operative implant collapse. | Class II | Alphatec Spine, Inc. |
| Dec 13, 2024 | Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reag... | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or... | Class II | Hologic, Inc. |
| Dec 12, 2024 | Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | Impella RP with SmartAssist; Product Number: 0046-0035; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Dec 12, 2024 | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | Impella RP Flex with SmartAssist; Product Number: 1000323; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Dec 12, 2024 | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburs... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 12, 2024 | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Ther... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 11, 2024 | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003... | Spore test strip monitoring system, designed for routine monitoring of sterilization processes, m... | Class II | HF Acquisition Co LLC |
| Dec 11, 2024 | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... | Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent... | Class II | MICROVENTION INC. |
| Dec 11, 2024 | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extraco... | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and Fle... | Class I | Nuwellis Inc |
| Dec 10, 2024 | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic aci... | False-positive MSI-H results generated by the Idylla MSI Test. | Class II | Biocartis Nv |
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Pa... | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized ... | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Dec 10, 2024 | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... | Class II | ev3 Inc |
| Dec 10, 2024 | EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new... | Class II | Encore Medical, LP |
| Dec 9, 2024 | Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Dec 9, 2024 | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400... | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching fr... | Class I | Maquet Cardiovascular, LLC |
| Dec 9, 2024 | JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L | Oxygen concentrator may melt or catch on fire during use. | Class I | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD |
| Dec 6, 2024 | Temporary Titanium Abutments | Certain definitive dental implant restoration cases may have included a temporary titanium abutme... | Class II | DDS Lab |
| Dec 6, 2024 | Portrait Core Services, a set of software services that enable the communicat... | There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... | Class II | GE Medical Systems, LLC |
| Dec 6, 2024 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could ... | Class I | Fresenius Kabi USA, LLC |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 5, 2024 | Dialyzer Optiflux 160NRe | Potential for internal blood leaks due to cracked polyurethane | Class II | Fresenius Medical Care Holdings, Inc. |
| Dec 5, 2024 | LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 4, 2024 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... | Class II | Augustine Temperature Management, LLC |
| Dec 4, 2024 | Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... | Incorrect catheter connector within the kit resulting in inability to provide a secure connection... | Class II | B. Braun Medical, Inc. |
| Dec 4, 2024 | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... | Class II | Augustine Temperature Management, LLC |
| Dec 4, 2024 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... | Class II | Augustine Temperature Management, LLC |
| Dec 4, 2024 | Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... | Due to an increase in complaint that the percutaneous reference pin would not fit into the patien... | Class II | Medtronic Navigation, Inc. |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACT... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPAT... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-... | Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacti... | Class II | Stryker Corporation |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TIS... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCI... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
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.