Medical Device Recalls

Recalls

Featured on Recalls

Regulatory & Quality

Beyond Air Nabs CE Mark for LungFit PH System Beyond Air Nabs CE Mark for LungFit PH System

The approval comes after what analyst’s report was a disappointing US commercial rollout of the system.

byKatie Hobbins, Managing Editor

Dec 2, 2024

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3 Min Read

Regulatory & Quality

FDA Recall Roundup: October 2024 FDA Recall Roundup: October 2024

byKatie Hobbins

Nov 21, 2024

10 Slides

Regulatory & Quality

Percussionaire Phasitron 5 Circuit Recall Designated Class I Percussionaire Phasitron 5 Circuit Recall Designated Class I

byKatie Hobbins

Nov 1, 2024

2 Min Read

FDA product removal icon

Regulatory & Quality

Hologic’s BioZorb Marker FDA Woes Continue Hologic’s BioZorb Marker FDA Woes Continue

byKatie Hobbins

Oct 29, 2024

3 Min Read

Regulatory & Quality

Smiths Medical Tracheostomy Tube Recall Grabs Class I Identification Smiths Medical Tracheostomy Tube Recall Grabs Class I Identification

byKatie Hobbins

Oct 28, 2024

1 Min Read

Obsidio Conformable Embolic

Regulatory & Quality

Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization

byKatie Hobbins

Oct 23, 2024

2 Min Read

More from Recalls

air embolism

Regulatory & Quality

Zyno Medical Z800 Infusion Pump Recall Details Danger of Air Embolism

Zyno Medical Z800 Infusion Pump Recall Details Danger of Air Embolism

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Mercury Medical Recall Neo-Tee T-Piece Resuscitators

Mercury Medical Recall Neo-Tee T-Piece Resuscitators

byKatie Hobbins, Managing Editor

Philips

Regulatory & Quality

Philips Respironics Corrects Trilogy Ventilators Software, Use Instructions

Philips Respironics Corrects Trilogy Ventilators Software, Use Instructions

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Gilead Sciences Recall Veklury for Injection 100 mg/Vial

Gilead Sciences Recall Veklury for Injection 100 mg/Vial

byKatie Hobbins, Managing Editor

FDA Recall

Regulatory & Quality

Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction

Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction

byKatie Hobbins, Managing Editor

B. Braun Medical

Regulatory & Quality

B. Braun Medical Adds Another Infusomat Pump to 2023 Recall

B. Braun Medical Adds Another Infusomat Pump to 2023 Recall

byKatie Hobbins, Managing Editor

Ivenix infusion system

Regulatory & Quality

Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024

Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024

byKatie Hobbins, Managing Editor

FreeStyle Libre 3

Regulatory & Quality

Abbott FreeStyle Libre 3 CGM Recall Designated Class I

Abbott FreeStyle Libre 3 CGM Recall Designated Class I

byKatie Hobbins, Managing Editor

McGrath MAC Video Laryngoscope

Regulatory & Quality

Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall

Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall

byKatie Hobbins, Managing Editor

Blood Clot

Regulatory & Quality

Six Deaths Connected to Inari ClotTriever XL Recall

Six Deaths Connected to Inari ClotTriever XL Recall

byKatie Hobbins, Managing Editor

Vivo 45 LS Ventilator

Regulatory & Quality

Breas Medical Initiates Vivo 45 LS Ventilator Correction

Breas Medical Initiates Vivo 45 LS Ventilator Correction

byKatie Hobbins, Managing Editor

Medtronic NIM Vital Nerve Monitoring System

Regulatory & Quality

Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I

Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I

byKatie Hobbins, Managing Editor

Infusion

Regulatory & Quality

Smiths Medical Corrects CADD-Solis Software

Smiths Medical Corrects CADD-Solis Software

byKatie Hobbins, Managing Editor

Recall

Regulatory & Quality

Bausch + Lomb/Synergetics Recall I-Pack Injection Kits

Bausch + Lomb/Synergetics Recall I-Pack Injection Kits

byKatie Hobbins, Managing Editor

Product recall

Regulatory & Quality

Baxter Recall Life2000 Ventilators with Attached Battery Charger Dongle

Baxter Recall Life2000 Ventilators with Attached Battery Charger Dongle

byKatie Hobbins, Managing Editor

Instructions for use

Regulatory & Quality

Philips Updates Sense XL Torso Coil Use Instructions

Philips Updates Sense XL Torso Coil Use Instructions

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I

Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I

byKatie Hobbins, Managing Editor

Product recall

Regulatory & Quality

OptumHealth Nimbus II Pump System Identified as Class I Recall

OptumHealth Nimbus II Pump System Identified as Class I Recall

byKatie Hobbins, Managing Editor

recall

Regulatory & Quality

Hologic BioZorb Marker Recall Identified as Class I

Hologic BioZorb Marker Recall Identified as Class I

byKatie Hobbins, Managing Editor

Masimo recall

Regulatory & Quality

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

byKatie Hobbins, Managing Editor

Trilogy Evo Ventilators

Regulatory & Quality

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

byKatie Hobbins, Managing Editor

Obsidio Conformable Embolic

Regulatory & Quality

Boston Scientific Class I Recall Linked to Two Deaths

Boston Scientific Class I Recall Linked to Two Deaths

byKatie Hobbins, Managing Editor

Abbott HeartMate 3 heart pump (left ventricular assist device) designed to help the heart pump blood to the rest of the body.

14 Deaths Connected to Latest Abbott HeartMate Recall

14 Deaths Connected to Latest Abbott HeartMate Recall

byAmanda Pedersen

Philips FDA compliance

Philips Faces Consent Decree that Restricts Sales of New Sleep Apnea Devices

Philips Faces Consent Decree that Restricts Sales of New Sleep Apnea Devices

byKatie Hobbins, Managing Editor

Medical device recall

Regulatory & Quality

Vyaire Medical Recalls AirLife Manual Resuscitators

Vyaire Medical Recalls AirLife Manual Resuscitators

byKatie Hobbins, Managing Editor

Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn

Regulatory & Quality

FDA Facing Increased Scrutiny Over Medical Device Recalls

FDA Facing Increased Scrutiny Over Medical Device Recalls

byKatie Hobbins, Managing Editor

Regulatory & Quality

Philips Scandal Is a Blight on Medtech's Reputation

Philips Scandal Is a Blight on Medtech's Reputation

byAmanda Pedersen

Philips Trilogy Evo Ventilator System.png

Regulatory & Quality

Philips Recall Woes Continue

Philips Recall Woes Continue

byKatie Hobbins, Managing Editor

RECALL UPDATES-5.png

Regulatory & Quality

Medtronic Recalls TurboHawk Due to HawkOne Recall

Medtronic Recalls TurboHawk Due to HawkOne Recall

byAmanda Pedersen