BEUDAMED
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    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    FDA Recall
    Terminated ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·March 17, 2021

    ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.

    FDA Recall
    Terminated ·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·February 28, 2020

    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JIX·August 24, 2017

    Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

    FDA Recall
    Terminated ·Ossur Grjothals 5 Reykjavik Ireland·Product code ISH·October 21, 2005

    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·May 6, 2015

    RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·September 21, 2018

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015

    Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015

    O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018

    Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·February 14, 2022

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·February 14, 2022

    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·July 10, 2019

    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJK·May 20, 2014

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Recall
    Terminated ·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015

    Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    FDA Recall
    Terminated ·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018

    Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    FDA Recall
    Terminated ·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018

    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

    FDA Recall
    Terminated ·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018

    GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.

    FDA Recall
    Terminated ·Cardinal Health, Inc·Product code EWO·September 16, 2008

    Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm

    FDA Recall
    Terminated ·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018

    Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm

    FDA Recall
    Terminated ·Angiotech (Manan Medical Products, Inc.)·Product code DWO·December 18, 2018