21 results
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59ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Recall
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Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTO·July 9, 2009
Ventilator Tubing
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTO·September 23, 2015
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTL·September 7, 2012
RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code CAI·November 13, 2013
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTM·September 12, 2003
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTM·September 12, 2003
Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code JAY·October 14, 2005
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code KDD·May 11, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code KDC·May 11, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code KDC·May 11, 2021
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
FDA Recall
Terminated
·Medical Action Industries, Inc.·Product code KDC·October 12, 2022
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code LXH·December 14, 2016
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code LXH·December 14, 2016
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code LXH·December 14, 2016
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code LXH·December 14, 2016
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Recall
Terminated
·MEDLINE INDUSTRIES INC·Product code LXH·December 14, 2016
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
FDA Recall
Open, Classified
·Medline Industries Inc·Product code LRO·April 30, 2021
Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
FDA Recall
Terminated
·Solta Medical, Inc.·Product code ONG·December 15, 2010
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code MDB·June 27, 2018
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code MDB·June 27, 2018