BEUDAMED
    40 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 24, 2008

    LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. LIFEPAK CR Plus AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 24, 2008

    Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·May 15, 2025

    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Recall
    Terminated ·Mizuho OSI·Product code JEA·December 17, 2012

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code LXH·July 29, 2021

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Recall
    Terminated ·Mizuho OSI·Product code FWZ·March 28, 2017

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Recall
    Terminated ·Mizuho OSI·Product code GDC·December 14, 2015

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Recall
    Terminated ·Mizuho OSI·Product code JEA·October 14, 2019

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code GDC·February 8, 2021

    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code IYN·April 11, 2024

    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·March 13, 2012

    Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378I ; 21) STERILE PAIN PACK-LF, Pack Number DYNJ0384670F ; 22) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265G ; 23) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265I ; 24) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265J ; 25) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265K ; 26) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265L ; 27) EPIDURAL PAIN INJ (O.I) PK-LF, Pack Number DYNJ0429265M; 28) PANCREAS DONOR PACK-LF, Pack Number DYNJ0429318F ; 29) MINOR ACUTE PACK-LF , Pack Number DYNJ0484979C ; 30) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0487701G ; 31) LOCAL PACK-LF , Pack Number DYNJ0554526I ; 32) ESI PACK-LF , Pack Number DYNJ0562716G ; 33) PAIN MANAGEMENT - EDOC PACK-LF, Pack Number DYNJ0625993I; 34) BGMC MJR ORAL/MAXILLO PACK-LF , Pack Number DYNJ0664646B ; 35) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964J ; 36) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964K ; 37) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964L ; 38) DSA PACK-LF , Pack Number DYNJ0843713D ; 39) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0904575C ; 40) LOCALS PACK-LF, Pack Number DYNJ0939707; 41) EP TRAY , Pack Number DYNJ21808D ; 42) PAIN MANAGEMENT , Pack Number DYNJ26879B ; 43) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384L ; 44) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384M ; 45) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384N ; 46) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384O ; 47) FACET , Pack Number DYNJ28549D ; 48) PAIN MANAGEMENT PACK, Pack Number DYNJ30042A ; 49) PAIN MANAGEMENT KIT , Pack Number DYNJ30500; 50) PAIN MANAGEMENT KIT , Pack Number DYNJ30500A ; 51) PAIN BLOCKS PACK, Pack Number DYNJ31717B ; 52) PAIN BLOCKS PACK, Pack Number DYNJ31717C ; 53) PAIN BLOCKS PACK, Pack Number DYNJ31717D ; 54) RADIOLOGY EPIDURAL 0906005-LF , Pack Number DYNJ32775K ; 55) UNIVERSAL BLOCK TRAY;EXT LINE , Pack Number DYNJ33057; 56) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352B ; 57) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352C ; 58) LOCAL BASIC , Pack Number DYNJ34418I ; 59) LOCAL BASIC , Pack Number DYNJ34418L ; 60) LOCAL BASIC , Pack Number DYNJ34418M ; 61) PATIENT PREP TRAY , Pack Number DYNJ34489D ; 62) SOFT PAIN TRAY-LF , Pack Number DYNJ35270C ; 63) PAIN MANAGEMENT , Pack Number DYNJ36528A ; 64) PAIN MANAGEMENT , Pack Number DYNJ36528B ; 65) LOCAL PROCEDURE PACK, Pack Number DYNJ38148C ; 66) LOCAL PROCEDURE PACK, Pack Number DYNJ38148D ; 67) BASIC PAIN PACK-LF, Pack Number DYNJ38623F ; 68) BASIC PAIN PACK-LF, Pack Number DYNJ38623G ; 69) BASIC PAIN PACK-LF, Pack Number DYNJ38623I; 70) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number DYNJ39178B ; 71) PAIN PROCEDURE PACK , Pack Number DYNJ40804D ; 72) BLOCK PACK, Pack Number DYNJ44205B ; 73) BLOCK PACK, Pack Number DYNJ44205D ; 74) EP PACK 319704, Pack Number DYNJ44602C ; 75) PAIN PACK , Pack Number DYNJ45913A ; 76) PAIN PACK , Pack Number DYNJ45913B ; 77) PAIN PACK , P

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFT·April 8, 2024

    Synapse PACS - Version 7.3.000

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 10, 2024

    Synapse PACS - Version 7.1.000US

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 10, 2024

    Synapse PACS - Version 7.2.200

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 10, 2024