Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Epimed International
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Medical Devices·263 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
3-Way Standardbore Stopcock. Product Code: AMS-100.
Medical Devices·200 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
Medical Devices·156 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Medical Devices·300 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
Medical Devices·0 affected·Jul 24, 2017
High RiskFDA
Zimmer Orthopedic Mfg Ltd
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Medical Devices·7 affected·Jul 24, 2017
High RiskFDA
Qiagen, Gmbh
QIAamp DSP Virus Kit Cat. No. 60704
Medical Devices·555 affected·Jul 22, 2017
High RiskFDA
Synthes (usa) Products Llc
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Medical Devices·4 affected·Jul 21, 2017
High RiskFDA
Stryker Medical Division Of Stryker Corporation
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Medical Devices·11,160 affected·Jul 21, 2017
High RiskFDA
Howmedica Osteonics Corp.
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Medical Devices·255 affected·Jul 21, 2017
High RiskFDA
Medline Industries Inc
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, ...
Medical Devices·5,722 affected·Jul 18, 2017
High RiskFDA
Vyaire Medical
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, R...
Medical Devices·5,400 affected·Jul 18, 2017
High RiskFDA
Becton Dickinson & Co.
BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab speci...
Medical Devices·0 affected·Jul 18, 2017
High RiskFDA
Becton Dickinson & Co.
BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens,...
Medical Devices·0 affected·Jul 18, 2017
High RiskFDA
Becton Dickinson & Co.
BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specime...
Medical Devices·0 affected·Jul 18, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix conf...
Medical Devices·3,433 affected·Jul 18, 2017
High RiskFDA
Covidien Lp
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Spo...
Medical Devices·33,280 affected·Jul 17, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ...
Medical Devices·15 affected·Jul 14, 2017
High RiskFDA
Panoramic Rental Corp.
PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Medical Devices·13,340 affected·Jul 14, 2017
High RiskFDA
Pentax Of America Inc
Video Cystoscope models ECY-1570 and ECY-1570K
Medical Devices·24 affected·Jul 13, 2017
High RiskFDA
Bomimed
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. T...
Medical Devices·680 affected·Jul 13, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Medical Devices·19 affected·Jul 12, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Zimmer Dental Inc
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Medical Devices·349 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, RE...
Medical Devices·13,235 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; ...
Medical Devices·423 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT5...
Medical Devices·76 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IM...
Medical Devices·86 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
THREAD RETRIEVAL DRILL REF 2224
Medical Devices·237 affected·Jul 10, 2017
High RiskFDA
Amendia, Inc
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Medical Devices·41 affected·Jul 7, 2017
High RiskFDA
Ondamed Inc
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation...
Medical Devices·585 affected·Jul 7, 2017
High RiskFDA
Phadia Us Inc
Phadia 1000 Instrument, Article Number 12-3800-01.
Medical Devices·70 affected·Jul 5, 2017
High RiskFDA
Cosman Medical, Llc
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15...
Medical Devices·11,250 affected·Jul 5, 2017
High RiskFDA
Orthofix Srl
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit...
Medical Devices·416 affected·Jul 5, 2017
High RiskFDA
Baxter Healthcare Corporation
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended fo...
Medical Devices·15,144 affected·Jul 5, 2017
High RiskFDA
Baxter Healthcare Corporation
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intende...
Medical Devices·23,732 affected·Jul 5, 2017
High RiskFDA
Centurion Medical Products Corporation
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code ...
Medical Devices·0 affected·Jul 5, 2017
High RiskFDA
Avid Medical, Inc.
AVID Medical QA Pack AV10654-10
Medical Devices·330 affected·Jul 3, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Medical Devices·429 affected·Jun 30, 2017
High RiskFDA
R82 A/s
Heron toilet and bath chair Model 880505-01 & 880505-11
Medical Devices·687 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Medical Devices·367 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medical Devices·4 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Medical Devices·98 affected·Jun 29, 2017