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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to quality issues, USA

1 year ago •source fda.gov • details

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator… See more

#medicaldevices #unitedstates

Recalls Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to qual... photo #1
312   Comments Comment

Recall notice

Baxter Life2000 Ventilator - recalled due to battery charger dongle damage, USA

1 year ago •source fda.gov • details

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. The impacted ventilators… See more

#recall #medicaldevices #unitedstates

Recalls Baxter Life2000 Ventilator - recalled due to battery charger dongle damage Baxter International Inc.... photo #1
312   Comments Comment

Recall notice

Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction, USA

1 year ago •source fda.gov • details

Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability… See more

#recall #medicaldevices #unitedstates

Recalls Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction Medl... photo #1
312   Comments Comment

Recall notice

Ethicon Megadyne Mega Soft Pediatric Patient Return Electrode - recalled due to Reports of patient burn injuries, USA

1 year ago •source fda.gov • details

MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports… See more

#recall #medicaldevices #unitedstates

Recalls Ethicon Megadyne Mega Soft Pediatric Patient Return Electrode - recalled due to Reports of patient b... photo #1
312   Comments Comment

Recall notice

Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

1 year ago •source fda.gov • details

In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium… See more

#recall #medicaldevices #unitedstates

Recalls Medline and Centurion Convenience kits - recalled due to lack of sterility In direct response to the... photo #1
312   Comments Comment

Recall notice

InfuTronix Nimbus Ambulatory Infusion Pump System recalled due to customer complaints, USA

1 year ago •source fda.gov • details

InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the… See more

#medicaldevices #unitedstates

Recalls InfuTronix Nimbus Ambulatory Infusion Pump System recalled due to customer complaints InfuTronix, LL... photo #1
312   Comments Comment

Recall notice

Several Brand CPAP and BIPAP Masks with Magnets - recalled due to interference with medical implants, USA

1 year ago •source fda.gov • details

On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or… See more

#medicaldevices #unitedstates

Recalls Several Brand CPAP and BIPAP Masks with Magnets - recalled due to interference with medical implants... photo #1
312   Comments Comment

Recall notice

Megadyne Electrodes - Alert to Use for ages 12+ only, USA

1 year ago •source fda.gov • details

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA… See more

#recall #medicaldevices #unitedstates

Recalls Megadyne Electrodes - Alert to Use for ages 12+ only Megadyne issued a Class 1 Medical Device Correc... photo #1
312   Comments Comment

Recall notice

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility, USA

1 year ago •source fda.gov • details

Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to… See more

#recall #medicaldevices #unitedstates

Recalls Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility Av... photo #1
312   Comments Comment

Recall notice

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance, USA

1 year ago •source fda.gov • details

Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and… See more

#recall #medicaldevices #unitedstates

Recalls Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack... photo #1
312   Comments Comment

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