Data Foundry

All years

Medical device recalls reported in 2023

← Newer · Older →

ReportedRecallClassProductFirm
2023-11-08Z-0168-2024Class IIMcGrath Mac 2Covidien
2023-11-08Z-0169-2024Class IIMcGrath Mac 2Covidien
2023-11-08Z-0170-2024Class ISenhance Surgical SystemAsensus Surgical Inc
2023-11-08Z-0187-2024Class IIAZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CMMICROVENTION INC.
2023-11-08Z-0195-2024Class IISiemens Cios AlphaSiemens Medical Solutions USA, Inc
2023-11-08Z-0196-2024Class II***Updated 12/4/23***Siemens Medical Solutions USA, Inc
2023-11-08Z-0197-2024Class IIQ2 Multiport Extension setQuest Medical, Inc.
2023-11-08Z-0198-2024Class IIRX Daytona PlusRandox Laboratories Ltd.
2023-11-08Z-0199-2024Class IIRX Daytona PlusRandox Laboratories Ltd.
2023-11-08Z-0200-2024Class IIRX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900Randox Laboratories Ltd.
2023-11-08Z-0201-2024Class IIRX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000Randox Laboratories Ltd.
2023-11-08Z-0202-2024Class IIRX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000Randox Laboratories Ltd.
2023-11-08Z-0203-2024Class IICoapt Dome ElectrodeCoapt LLC
2023-11-08Z-0204-2024Class IICoapt ControlSeal ElectrodeCoapt LLC
2023-11-08Z-0205-2024Class IISmiths Medical Portex Bivona Pediatric Tracheostomy TubeSmiths Medical ASD Inc.
2023-11-08Z-0206-2024Class IIRayCare 5B and 6A including service packs- An oncology information…RAYSEARCH LABORATORIES AB
2023-11-08Z-0207-2024Class IINova Biomedical Prime Plus Analyzer -Intended to measure certain…Nova Biomedical Corporation
2023-11-08Z-0208-2024Class IINova Stat Profile Prime Plus POC AnalyzerNova Biomedical Corporation
2023-11-08Z-0209-2024Class IIAbbott NT2000iX RadiofrequencyAbbott
2023-11-08Z-0210-2024Class IIVasoview 6 ProMaquet Cardiovascular, LLC
2023-11-08Z-0211-2024Class IICosmedent FlexiCup Composite Finishing & Polishing SystemCosmedent, Inc.
2023-11-08Z-0212-2024Class IIHILLROM PROGRESSA+ BEDBaxter Healthcare Corporation
2023-11-08Z-0213-2024Class IIUnity CR Femur RightCorin Ltd
2023-11-08Z-0214-2024Class IIUnity Total Knee SystemCorin Ltd
2023-11-08Z-0215-2024Class IIXpert Xpress Strep ACepheid
2023-11-08Z-0216-2024Class IIXpert Xpress Strep ACepheid
2023-11-08Z-0217-2024Class IILEAD 3387S-40 STIMLOC DBSMedtronic Neuromodulation
2023-11-01Z-0042-2024Class IIOne Step Pregnancy Test REF 100-01Universal Meditech Inc.
2023-11-01Z-0043-2024Class IIOne Step Ovulation Test REF 200-01Universal Meditech Inc.
2023-11-01Z-0044-2024Class IIHealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis…Universal Meditech Inc.
2023-11-01Z-0045-2024Class IIHealthyWiser UriTest" UTI Test Strips REF 900-UTIUniversal Meditech Inc.
2023-11-01Z-0046-2024Class IIHealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test stripsUniversal Meditech Inc.
2023-11-01Z-0047-2024Class IIHealthyWiser pH-Aware pH 4Universal Meditech Inc.
2023-11-01Z-0048-2024Class IIDeTec hCG Pregnancy Urine Test Cassette FormatUniversal Meditech Inc.
2023-11-01Z-0049-2024Class IIAm I Pregnant? One Step HCG Pregnancy Test REF 100-17Universal Meditech Inc.
2023-11-01Z-0050-2024Class IITo Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10Universal Meditech Inc.
2023-11-01Z-0051-2024Class IIPrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTSUniversal Meditech Inc.
2023-11-01Z-0052-2024Class IIPrestiBio Ovulation Strips REF 200-4 60 LH Test StripsUniversal Meditech Inc.
2023-11-01Z-0053-2024Class IIPrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60…Universal Meditech Inc.
2023-11-01Z-0054-2024Class IIPrestiBio Pregnancy Strips REF 100-4 25 HCG Test StripsUniversal Meditech Inc.
2023-11-01Z-0055-2024Class IIPrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTSUniversal Meditech Inc.
2023-11-01Z-0056-2024Class IIPrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREEUniversal Meditech Inc.
2023-11-01Z-0057-2024Class IIPrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10Universal Meditech Inc.
2023-11-01Z-0058-2024Class IIDiagnosUS One Step LH Ovulation Test Strip REF 200-07Universal Meditech Inc.
2023-11-01Z-0059-2024Class IIDiagnosUS SARS-CoV-2 AntibodyUniversal Meditech Inc.
2023-11-01Z-0060-2024Class IIDiagnosUS¿ One Step FSH Menopausal TestUniversal Meditech Inc.
2023-11-01Z-0061-2024Class IILem Fertility hCG Pregnancy Urine Test REF 100-12Universal Meditech Inc.
2023-11-01Z-0062-2024Class IILem Fertility LH Ovulation TestUniversal Meditech Inc.
2023-11-01Z-0063-2024Class IIDiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12Universal Meditech Inc.
2023-11-01Z-0064-2024Class IIDiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13Universal Meditech Inc.
2023-11-01Z-0065-2024Class IIDiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27Universal Meditech Inc.
2023-11-01Z-0066-2024Class IIDiagnosUS Pregnancy Test Midstream REF 100-17Universal Meditech Inc.
2023-11-01Z-0067-2024Class IIDiagnosUS Ovulation Predictor Midstream REF 200-17Universal Meditech Inc.
2023-11-01Z-0068-2024Class IIOMTMO One Step OvulationUniversal Meditech Inc.
2023-11-01Z-0111-2024Class IAstral 100 and Astral 150 ventilatorsResMed Ltd.
2023-11-01Z-0123-2024Class I8713051UB. Braun Medical, Inc.
2023-11-01Z-0124-2024Class I8713052UB. Braun Medical, Inc.
2023-11-01Z-0126-2024Class IISynCardia 50cc TAH-tSynCardia Systems LLC
2023-11-01Z-0127-2024Class IITruDi Navigation SystemAcclarent, Inc.
2023-11-01Z-0137-2024Class IIMaquet Acrobat-i Vacuum Stabilizer System Intended for use during…Maquet Cardiovascular, LLC
2023-11-01Z-0138-2024Class IICentricity PACS-IWGE Healthcare
2023-11-01Z-0139-2024Class IICentricity PACS-IW with Universal ViewerGE Healthcare
2023-11-01Z-0140-2024Class IICentricity Universal ViewerGE Healthcare
2023-11-01Z-0141-2024Class IIPortex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin…Smiths Medical ASD Inc.
2023-11-01Z-0142-2024Class IICentricity Universal Viewer Workflow ManagerGE Healthcare
2023-11-01Z-0143-2024Class IIUniversal Viewer Workflow ManagerGE Healthcare
2023-11-01Z-0145-2024Class IMonoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0146-2024Class IMonoject" 6 mL Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0147-2024Class IMonoject" 12 mL Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0148-2024Class IMonoject 20 mL Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0149-2024Class IMonoject" 35 mL Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0150-2024Class IMonoject" 60 mL Syringe Luer-Lock Tip Soft PackCardinal Health 200, LLC
2023-11-01Z-0152-2024Class IIPreat REF 9007121Preat Corp
2023-11-01Z-0153-2024Class IIPreat REF 9007123Preat Corp
2023-11-01Z-0154-2024Class IIPreat REF 9007124Preat Corp
2023-11-01Z-0155-2024Class IISOZO Bilateral Arm L-Dex SoftwareImpedimed Limited
2023-11-01Z-0156-2024Class IIOmega Medical Imaging Elevating Monitor SuspensionOmega Medical Imaging, Inc.
2023-11-01Z-0157-2024Class IIJOURNEY II BCS ARTICULAR INSERTSmith & Nephew, Inc.
2023-11-01Z-0158-2024Class IIJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6Smith & Nephew, Inc.
2023-11-01Z-0159-2024Class IIEmbrace2- Indicated for use as an adjunct to seizure monitoring of…EMPATICA SRL
2023-11-01Z-0160-2024Class IIOmega Medical Imaging Elevating Monitor Suspension SystemsOmega Medical Imaging, Inc.
2023-11-01Z-0161-2024Class IIGrafton DBM CrunchMedtronic Sofamor Danek USA Inc
2023-11-01Z-0162-2024Class IIGrafton DBMMedtronic Sofamor Danek USA Inc
2023-11-01Z-0163-2024Class IIGrafton DMB MatrixMedtronic Sofamor Danek USA Inc
2023-11-01Z-0164-2024Class IIGrafton DBM Matrix StripsMedtronic Sofamor Danek USA Inc
2023-11-01Z-0165-2024Class IIGrafton DBM OrthoblendMedtronic Sofamor Danek USA Inc
2023-11-01Z-0166-2024Class IIGrafton Plus DBM PasteMedtronic Sofamor Danek USA Inc
2023-11-01Z-0167-2024Class IIGrafton DBM PuttyMedtronic Sofamor Danek USA Inc
2023-11-01Z-0171-2024Class IIGeneral PackAmerican Contract Systems, Inc.
2023-11-01Z-0172-2024Class IILAVHAmerican Contract Systems, Inc.
2023-11-01Z-0173-2024Class IIBreast Plastics PackAmerican Contract Systems, Inc.
2023-11-01Z-0174-2024Class IIRobotics Pack SAHAmerican Contract Systems, Inc.
2023-11-01Z-0175-2024Class IICVS PCSU SJHAmerican Contract Systems, Inc.
2023-11-01Z-0176-2024Class IIPediatric Heart SJHAmerican Contract Systems, Inc.
2023-11-01Z-0177-2024Class IIVascAmerican Contract Systems, Inc.
2023-11-01Z-0178-2024Class IIRobotics PackAmerican Contract Systems, Inc.
2023-11-01Z-0179-2024Class IIRobotics PackAmerican Contract Systems, Inc.
2023-11-01Z-0180-2024Class IISub Q Recorder PackAmerican Contract Systems, Inc.
2023-11-01Z-0181-2024Class IIPediatric Urology Wolson PackAmerican Contract Systems, Inc.
2023-11-01Z-0182-2024Class IICath Cardiac PackAmerican Contract Systems, Inc.
2023-11-01Z-0183-2024Class IIOPMI LUMERA 300Carl Zeiss Suzhou Co., Ltd.
2023-10-25Z-0075-2024Class IOlympus High-Flow Insufflation UnitOlympus Corporation of the Americas
2023-10-25Z-0094-2024Class ISapphire Infusion PumpsEITAN MEDICAL LTD
2023-10-25Z-0112-2024Class IIMonojectCardinal Health 200, LLC
2023-10-25Z-0113-2024Class IIstryker Tornier Perform Reversed Augmented Glenoid Lateralized…Tornier, Inc
2023-10-25Z-0114-2024Class IIHydroPICC 5Fr Dual LumenAccess Vascular, Inc
2023-10-25Z-0115-2024Class IIHydroPICC 5Fr Dual Lumen Maximal Barrier KitAccess Vascular, Inc
2023-10-25Z-0116-2024Class IIDeRoyal Head and Neck procedure kitDeRoyal Industries Inc
2023-10-25Z-0117-2024Class IIMEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated…MEDLINE INDUSTRIES, LP - Northfield
2023-10-25Z-0118-2024Class IIMEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated…MEDLINE INDUSTRIES, LP - Northfield
2023-10-25Z-0119-2024Class IIMEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with…MEDLINE INDUSTRIES, LP - Northfield
2023-10-25Z-0120-2024Class IIMEDLINE ReNewal Harmonic ACE+7 Shears w/ AdvMEDLINE INDUSTRIES, LP - Northfield
2023-10-25Z-0121-2024Class IISenSight Connector PlugMedtronic Neuromodulation
2023-10-25Z-0122-2024Class IIFunctional MR V1OLEA MEDICAL
2023-10-25Z-0125-2024Class IIGladiatorNorth Coast Medical Inc
2023-10-18Z-0005-2024Class I10ML SYRINGE LUER LOCK W/OUT NEEDLEFresenius Medical Care Holdings, Inc.
2023-10-18Z-0006-2024Class I10ML SYRINGE LUER LOCK W/NEEDLEFresenius Medical Care Holdings, Inc.
2023-10-18Z-0007-2024Class I3ML Syringe Luer Lock with needle 20GX1Fresenius Medical Care Holdings, Inc.
2023-10-18Z-0028-2024Class I2008T Hemodialysis SYSFresenius Medical Care Holdings, Inc.
2023-10-18Z-0029-2024Class I2008T Hemodialysis System without CDXFresenius Medical Care Holdings, Inc.
2023-10-18Z-0030-2024Class I2008T Hemodialysis System w/BibagFresenius Medical Care Holdings, Inc.
2023-10-18Z-0031-2024Class I2008T GEN 2 Bibag without CDXFresenius Medical Care Holdings, Inc.
2023-10-18Z-0032-2024Class I2008T HD SYSFresenius Medical Care Holdings, Inc.
2023-10-18Z-0033-2024Class I2008T HD SYSFresenius Medical Care Holdings, Inc.
2023-10-18Z-0034-2024Class I2008T HD SYSFresenius Medical Care Holdings, Inc.
2023-10-18Z-0035-2024Class I2008T HD SYSFresenius Medical Care Holdings, Inc.
2023-10-18Z-0073-2024Class II3T Heater Cooler SystemLivaNova Deutschland GmbH
2023-10-18Z-0074-2024Class IICoventus Flower Orthopedics Flex-Thread TM 3Flower Orthopedics Corporation
2023-10-18Z-0076-2024Class IIMedfusion Syringe PumpSmiths Medical ASD Inc.
2023-10-18Z-0077-2024Class IIMedfusion Syringe PumpSmiths Medical ASD Inc.
2023-10-18Z-0078-2024Class IIMedfusion Syringe PumpSmiths Medical ASD Inc.
2023-10-18Z-0079-2024Class IIMedfusion Syringe PumpSmiths Medical ASD Inc.
2023-10-18Z-0080-2024Class IIMedfusion PLUNGER FLOAT PLATESmiths Medical ASD Inc.
2023-10-18Z-0081-2024Class IIMedfusion ASSEMBLY PLUNGER CASE LEFT 1/EASmiths Medical ASD Inc.
2023-10-18Z-0082-2024Class IICellQuicken AnalyzerRoyalVibe Health Ltd.
2023-10-18Z-0083-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0084-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0085-2024Class IIProcedure pack: Presource PBDSCardinal Health 200, LLC
2023-10-18Z-0086-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0087-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0088-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0089-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0090-2024Class IIProcedure pack: Presource PBDS CatCardinal Health 200, LLC
2023-10-18Z-0091-2024Class IIProcedure packs:Cardinal Health 200, LLC
2023-10-18Z-0092-2024Class IIPresource Fistulogram PackCardinal Health 200, LLC
2023-10-18Z-0093-2024Class IIBD Pyxis CII Safe ESCareFusion 303, Inc.
2023-10-18Z-0095-2024Class IIMED-810A Zemits NDPrime Laser productsAdvance-Esthetic LLC
2023-10-18Z-0096-2024Class IIGAMMEX NON-LATEX PI GREEN Surgical glovesAnsell Healthcare Products LLC
2023-10-18Z-0097-2024Class IINOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical glovesAnsell Healthcare Products LLC
2023-10-18Z-0098-2024Class IIREVERSE PROSTHESIS SHOULDER SYSTEMEncore Medical, LP
2023-10-18Z-0099-2024Class IIConstellation Vision SystemAlcon Research, LLC
2023-10-18Z-0100-2024Class IIAccess Thyroglobulin CalibratorsBeckman Coulter, Inc.
2023-10-18Z-0101-2024Class IIMAZOR X robotic guidance systemMazor Robotics Ltd
2023-10-18Z-0102-2024Class IIEMPOWR 3D Knee Tibial InsertEncore Medical, LP
2023-10-18Z-0103-2024Class IIEMPOWR Acetabular SystemEncore Medical, LP
2023-10-18Z-0104-2024Class IIMultichem S PlusTECHNO-PATH MANUFACTURING LTD.
2023-10-18Z-0105-2024Class IIMultichem IA PlusTECHNO-PATH MANUFACTURING LTD.
2023-10-18Z-0106-2024Class IIMultichem PTECHNO-PATH MANUFACTURING LTD.
2023-10-18Z-0107-2024Class IIDxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2023-10-18Z-0108-2024Class IITHUNDERBEATOlympus Corporation of the Americas
2023-10-18Z-0109-2024Class IITHUNDERBEATOlympus Corporation of the Americas
2023-10-18Z-0110-2024Class IIBD BACTEC Plus Aerobic/F Culture VialsBecton Dickinson & Co.
2023-10-11Z-0001-2024Class IArrow ErgoPackARROW INTERNATIONAL Inc.
2023-10-11Z-0002-2024Class IArrow ErgoPack CompleteARROW INTERNATIONAL Inc.
2023-10-11Z-0003-2024Class IArrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVCARROW INTERNATIONAL Inc.
2023-10-11Z-0004-2024Class IArrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance…ARROW INTERNATIONAL Inc.
2023-10-11Z-0008-2024Class IIProboscis/Piston AssemblyOrtho-Clinical Diagnostics, Inc.
2023-10-11Z-0009-2024Class IIGuider Softip Guide Catheter 6F PRE-SHAPED 40 90CMBoston Scientific Corporation
2023-10-11Z-0010-2024Class IIGuider Softip Guide Catheter 7F PRE-SHAPED 40 90CMBoston Scientific Corporation
2023-10-11Z-0011-2024Class IIGuider Softip Guide Catheter 8F PRE-SHAPED 40 90CMBoston Scientific Corporation
2023-10-11Z-0012-2024Class IIGuider Softip Guide Catheter 6F 90CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0013-2024Class IIGuider Softip Guide Catheter 7F 90CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0014-2024Class IIGuider Softip Guide Catheter 8F 90CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0015-2024Class IIGuider Softip Guide Catheter 5F PRE-SHAPED 40 90CMBoston Scientific Corporation
2023-10-11Z-0016-2024Class IIGuider Softip Guide Catheter 5F 90CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0017-2024Class IIGuider Softip Guide Catheter 6F PRE-SHAPED 40 100CMBoston Scientific Corporation
2023-10-11Z-0018-2024Class IIGuider Softip Guide Catheter 7F PRE-SHAPED 40 100CMBoston Scientific Corporation
2023-10-11Z-0019-2024Class IIGuider Softip Guide Catheter 8F PRE-SHAPED 40 100CMBoston Scientific Corporation
2023-10-11Z-0020-2024Class IIGuider Softip Guide Catheter 6F 100CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0021-2024Class IIGuider Softip Guide Catheter 7F 100CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0022-2024Class IIGuider Softip Guide Catheter 8F 100CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0023-2024Class IIGuider Softip Guide Catheter 5F PRE-SHAPED 40 100CMBoston Scientific Corporation
2023-10-11Z-0024-2024Class IIGuider Softip Guide Catheter 5F 100CM MULTI PURPOSEBoston Scientific Corporation
2023-10-11Z-0025-2024Class IIREF: 386862Becton Dickinson Infusion Therapy Systems Inc.
2023-10-11Z-0027-2024Class IIBard Marquee Disposable Core Biopsy Instrument KitBard Peripheral Vascular Inc
2023-10-11Z-0036-2024Class IIMeera Mobile Operating Table-to support and position the patient…Getinge Usa Sales Inc
2023-10-11Z-0037-2024Class IIAPI3200MD Mass SpectrometerAB Sciex, LLC
2023-10-11Z-0038-2024Class II4500MD Triple Quad Mass SpectrometerAB Sciex, LLC
2023-10-11Z-0039-2024Class IICitrine QTRAP Mass SpectrometerAB Sciex, LLC
2023-10-11Z-0040-2024Class IICitrine Triple Quad Mass SpectrometerAB Sciex, LLC
2023-10-11Z-0041-2024Class IIReal Intelligence CORI RIBlue Belt Technologies, Inc
2023-10-11Z-0069-2024Class IIZimmer Dermatome Blades- 10-pack boxes of bladesZimmer Surgical Inc
2023-10-11Z-0070-2024Class IIGS0008 2YROi CPS LLC
2023-10-11Z-0071-2024Class IILFS Flat screen arm system with surgical lamp for Models Aurora seriesDKK Dai-Ichi Shomei Co., Ltd.
2023-10-11Z-0072-2024Class IILFS Flat screen support arm systems without surgical lamp for models…DKK Dai-Ichi Shomei Co., Ltd.
2023-10-11Z-2520-2023Class IIIncisive CTPhilips Healthcare
2023-10-11Z-2648-2023Class II(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM…Siemens Medical Solutions USA, Inc
2023-10-11Z-2649-2023Class IICenturion Sterile CirClamp with 1MEDLINE INDUSTRIES, LP - Northfield
2023-10-11Z-2650-2023Class IIIceCure Cryoablation System ProSense -Intended for cryogenic…Icecure Medical Ltd
2023-10-11Z-2651-2023Class IIPuritan Bennett Cuff Pressure ManagerCovidien

← Newer · Older →