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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 921–940 of 1,000 recalls

Class IOngoing

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

Smiths Medical ASD Inc.

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

February 7, 2024 · DeviceView details →
Class IOngoing

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use

Medos International Sarl

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

February 2, 2024 · Device
View details →
Class IOngoing

stay-safe /Luer Lock Adapter 4 in

Fresenius Medical Care Holdings, Inc.

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

January 23, 2024 · DeviceView details →
Class IOngoing

stay-safe /Luer Lock Catheter Ext. 18 in

Fresenius Medical Care Holdings, Inc.

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

January 23, 2024 · DeviceView details →
Class IOngoing

stay-safe /Luer Catheter Ext. 6 in

Fresenius Medical Care Holdings, Inc.

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

January 23, 2024 · DeviceView details →
Class IOngoing

stay-safe /Luer Lock Catheter Ext. 12 in

Fresenius Medical Care Holdings, Inc.

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

January 23, 2024 · DeviceView details →
Class IOngoing

stay-safe /Safe Lock Catheter Ext. 12 in

Fresenius Medical Care Holdings, Inc.

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

January 23, 2024 · DeviceView details →
Class IOngoing

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Medtronic Neurosurgery

Potential for catheter disconnection from the patient line stopcock connectors.

January 22, 2024 · DeviceView details →
Class IOngoing

Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Medtronic Neurosurgery

Potential for catheter disconnection from the patient line stopcock connectors.

January 22, 2024 · DeviceView details →
Class IOngoing

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Medtronic Neurosurgery

Potential for catheter disconnection from the patient line stopcock connectors.

January 22, 2024 · DeviceView details →
Class IOngoing

Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Medtronic Neurosurgery

Potential for catheter disconnection from the patient line stopcock connectors.

January 22, 2024 · DeviceView details →
Class IOngoing

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Medtronic Neurosurgery

Potential for catheter disconnection from the patient line stopcock connectors.

January 22, 2024 · DeviceView details →
Class IOngoing

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22

Avanos Medical, Inc.

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

January 16, 2024 · DeviceView details →
Class IOngoing

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

Avanos Medical, Inc.

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

January 16, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
Class IOngoing

AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

Vyaire Medical

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

January 10, 2024 · DeviceView details →
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