Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 16801–16820 of 38,428 recalls
Recalled Item: Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602
The Issue: Torrent SuiteTM Dx analysis software, a component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225
The Issue: Torrent SuiteTM Dx analysis software, a component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774
The Issue: Torrent SuiteTM Dx analysis software, a component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer
The Issue: Torrent SuiteTM Dx analysis software, a component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM
The Issue: Needleholder incorrectly labeled as 200MM when the actual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: myCordella Patient Kit without ECG
The Issue: The firm have received reports of patients myCordella
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Data Manager
The Issue: The Brainlab Patient Data Manager software (PDM) in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4Fr x 20cm Single Lumen CT Midline Basic Tray
The Issue: that 3Fr size catheter placed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ
The Issue: The user may inadvertently enter Metric values into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Top
The Issue: SOMATOM go.Top (Models #11061640 & 11061648) with software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOMTEC-ARENA TTA2
The Issue: The firm discovered a software issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer
The Issue: for calibration error resulting in QC failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343
The Issue: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue Ortho TKA Pro v2.1 software installed on the Exactech
The Issue: The navigated values displayed when using the LPI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ra Medical Systems DABRA Catheter 5F (1.5mm)
The Issue: The firm has become aware there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical Philips M1355A Toco Transducer with belt wire/knob
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX)
The Issue: Fetal transducers distributed in advance of receiving 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.