Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2020 | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis ... | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... | Class III | Abbott Laboratories |
| Apr 1, 2020 | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... | Class III | Abbott Laboratories |
| Apr 1, 2020 | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8... | The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... | Class II | Ortho-Clinical Diagnostics |
| Apr 1, 2020 | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 80011... | The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... | Class II | Ortho-Clinical Diagnostics |
| Apr 1, 2020 | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENG... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Apr 1, 2020 | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LEN... | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Class II | Aesculap Implant Systems LLC |
| Mar 31, 2020 | Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... | False positive reaction on the reagent. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 31, 2020 | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guide... | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for... | Class II | Spectranetics Corporation |
| Mar 30, 2020 | iQ200 Series Urine Microscopy Analyzer- All part numbers | A defect in the SATA power adapter cable within the instrument s computer has the potential risk ... | Class II | Beckman Coulter Inc. |
| Mar 30, 2020 | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vant... | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking ... | Class II | Elekta Inc |
| Mar 30, 2020 | iChem¿VELOCITY Urine Chemistry System- | A defect in the SATA power adapter cable within the instruments computer has the potential risk f... | Class II | Beckman Coulter Inc. |
| Mar 30, 2020 | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be... | To reinforce existing instructions within the Directions for Use (DFU) and provide further guidan... | Class II | Boston Scientific Corporation |
| Mar 27, 2020 | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... | Class II | Stryker Sustainability Solutions |
| Mar 27, 2020 | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFK... | Sterile catheter kit packaging compromised. | Class II | Edwards Lifesciences, LLC |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydroge... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use On... | The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. | Class II | Becton Dickinson & Company |
| Mar 26, 2020 | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Us... | Due to a distribution error, product from the affected lot was shipped expired. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing cont... | During an FDA audit, it was discovered that the product was not properly registered with FDA. | Class II | Gentell, Inc |
| Mar 26, 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 26, 2020 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... | In affected software version, of Positron emission tomography and computed tomography system, the... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 25, 2020 | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr... | Incorrect expiration date | Class II | Abbott Vascular |
| Mar 24, 2020 | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ... | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ... | Class I | Smiths Medical ASD Inc. |
| Mar 23, 2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 11165... | The analyzer system may have an electrostatic discharge and sparking of the power supply provided... | Class II | Abbott Diagnostics Technologies AS |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-240 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 23, 2020 | Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the tr... | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... | Class II | The Magstim Company Limited |
| Mar 23, 2020 | Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Asp... | The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of... | Class II | INARI MEDICAL |
| Mar 23, 2020 | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated ... | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... | Class II | The Magstim Company Limited |
| Mar 23, 2020 | B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-... | Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by... | Class II | Janus Trade Group |
| Mar 23, 2020 | Olympus Pleuravideoscope, Model LTF-160 | There was no data to validate that the identified endo-therapy devices were compatible with certa... | Class II | Olympus Corporation of the Americas |
| Mar 23, 2020 | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... | There has been an increased trend in reports of catheters failing to deflate during use, which ma... | Class I | LeMaitre Vascular, Inc. |
| Mar 20, 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm ... | The product has an incorrect reference value for cadmium and an incorrect expected range. | Class III | Utak Laboratories Inc |
| Mar 20, 2020 | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U30... | Automated External Defibrillators may not detect a patient connection due to mechanical wear-thr... | Class II | Physio-Control, Inc. |
| Mar 18, 2020 | Frames Direct Prescription Spectacle Lenses included in the frame brands | The firm has become aware through their optical laboratory supplier that prescription spectacle ... | Class II | Frames Direct |
| Mar 18, 2020 | H12+ and patient cable for the H12+ Holter Recorders with the following devic... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | S4 and patient cable for the S4 Wireless Telemeter with the following device ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | ELI PC. The ELI PC Service automatically converts resting ECG recordings coll... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabil... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | T12. Incorporates wireless electrocardiographic technology to achieve the rea... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | Lead diagnostic electrocardiograph under the following device names: ELI 10, ... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 18, 2020 | X12+ and patient cable for the X12+ Telemeter with the following device name:... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Mar 17, 2020 | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Space between the device and the packaging permits excessive movement which could potentially lea... | Class II | Smith & Nephew, Inc. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
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.