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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 541–560 of 1,000 recalls

Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U1ESDIUC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Wright Medical Technology Inc

The package contents and package labeling do not match.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S3ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A3ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S1ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

The kit contains a non-sterile needle.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator,980X1ENAIQC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Wright Medical Technology Inc

The package contents and package labeling do not match.

November 4, 2021 · DeviceView details →
Class IITerminated

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

November 3, 2021 · DeviceView details →
Class IITerminated

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Magnolia Medical Technologies, Inc.

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

November 2, 2021 · DeviceView details →
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