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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 21–40 of 1,000 recalls

Class ITerminated

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

BearCare, Inc.

There have been reports of skin burns to children wearing the device.

May 10, 2023 · DeviceView details →
Class ITerminated

NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

NOXBOX LTD

Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

May 3, 2023 · DeviceView details →
Class IITerminated

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class IITerminated

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class IITerminated

ambIT Cassette Filter Male Luer, Product Code: 220266

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class IITerminated

SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class IITerminated

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class ITerminated

VentStar Basic (P)180, MP00351

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Set2Go Ventilation 12 (A), MP07968

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Seattle PAP Plus, MP02260

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Anesthesia WT (P)180, MP00374

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Anesthesia Set Coax 180, MP03384

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Watertrap (N) 180, MP00363

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Watertrap (P) 180, MP00361

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Anesthesia (N) 180, MP00333

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Ventstar Coax, MP03373

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

ID Circuit Basic (P) 180, MP01340

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Basic (P)250, MP00352

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Anesthesia Circuit Kit Coax 3, MP02732

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Ventstar Coax 180, MP03374

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
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