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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 28, 2023 | (1) Patient Information Center iX, Model No. 866389 (2) Patient Information ... | Push notifications may fail to send to the user under certain conditions. This could potentially ... | Class II | Philips North America |
| Nov 27, 2023 | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 Th... | Due to potential breakage during use. | Class II | Acumed LLC |
| Nov 27, 2023 | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic ... | A manufacturing event may contribute to elevated rates of false negative results while using gast... | Class II | BioFire Diagnostics, LLC |
| Nov 27, 2023 | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ... | Affected lots may experience increased calibration failures or an increase in falsely elevated re... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 27, 2023 | Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear M... | Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall dow... | Class II | Mirion Technologies (Capintec), Inc. |
| Nov 27, 2023 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nu... | A manufacturing event may contribute to elevated rates of false negative results while using gast... | Class II | BioFire Diagnostics, LLC |
| Nov 27, 2023 | Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA21... | The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is cont... | Class II | Philips Respironics, Inc. |
| Nov 23, 2023 | The device is a mobile x-ray system designed to work with Fujifilm's GOS and ... | When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.... | Class II | FUJIFILM Healthcare Americas Corporation |
| Nov 23, 2023 | Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rup... | Interference testing has shown that the presence of personal lubricants in the vaginal specimen c... | Class II | ACTIM OY |
| Nov 22, 2023 | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure tran... | Class II | DeRoyal Industries Inc |
| Nov 21, 2023 | AcuMatch Hip System, Catalog Number 142-32-27 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay An... | There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with t... | Class II | Beckman Coulter, Inc. |
| Nov 21, 2023 | QMS Tacrolimus Calibrators, Product code 10015573 | Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry dat... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 21, 2023 | Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, | There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... | Class II | Beckman Coulter, Inc. |
| Nov 21, 2023 | Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-00... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, ... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Novation Hip System, Catalog Numbers: 134-36-45 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 21, 2023 | Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-... | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most va... | Class II | Exactech, Inc. |
| Nov 20, 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoC... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Nov 20, 2023 | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta... | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instr... | Class II | Keystone Industries |
| Nov 20, 2023 | Calibration Serum Level 3 CAL2351 | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series inst... | Class II | Randox Laboratories Ltd. |
| Nov 20, 2023 | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) P... | One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of in... | Class II | THOR Photomedicine Ltd |
| Nov 20, 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S1... | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... | Class II | Olympus Corporation of the Americas |
| Nov 20, 2023 | Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... | Seal defects could compromise the ability of the product packaging to maintain sterility. | Class II | Medtronic Inc. |
| Nov 20, 2023 | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry... | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-ass... | Class II | Randox Laboratories Ltd. |
| Nov 20, 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S1... | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... | Class II | Olympus Corporation of the Americas |
| Nov 17, 2023 | VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number... | Cassette did not meet an 1n-process flow criterion. | Class II | Vero Biotech, LLC |
| Nov 17, 2023 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atla... | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains... | Class II | Draegerwerk Ag & Co. Kgaa |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... | Class II | Covidien |
| Nov 16, 2023 | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syri... | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with... | Class II | Becton Dickinson & Company |
| Nov 16, 2023 | V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc... | Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Th... | Class II | Steris Corporation |
| Nov 16, 2023 | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... | Class II | Covidien LP |
| Nov 15, 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopi... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 15, 2023 | Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-... | MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two po... | Class II | Landauer |
| Nov 15, 2023 | Sensica Urine Output System, Catalog Number SCCS1002 | BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/... | Class II | C.R. Bard Inc |
| Nov 15, 2023 | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Sp... | Incorrect product labeling. Exterior product box label does not match internal pouch label. | Class II | Spectranetics Corporation |
| Nov 15, 2023 | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3... | Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.... | Class II | Medtronic MiniMed, Inc. |
| Nov 15, 2023 | SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System | New User Manual with additional instructions for use and a hose and mask adapter provided by the ... | Class II | SoClean, Inc |
| Nov 15, 2023 | SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. | New User Manual with additional instructions for use and a hose and mask adapter provided by the ... | Class II | SoClean, Inc |
| Nov 15, 2023 | The INFX-8000F is designed to take advantage of the latest technological inno... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 15, 2023 | Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test o... | Class II | Baxter Healthcare Corporation |
| Nov 14, 2023 | BD Recanalization System, REF: BDRECANSYSTEM | Recanalization systems may be in a manufacturing mode that allows the system to continuously run ... | Class II | Bard Peripheral Vascular Inc |
| Nov 13, 2023 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | Possibility that the user is unable to resolve drill disconnection error messages. | Class II | Blue Belt Technologies, Inc |
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.