Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  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 1–20 of 1,000 recalls

Class ITerminated

regard Operative LAP, Item Number 800943001; surgical convenience kit

ROi CPS LLC

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

December 18, 2023 · DeviceView details →
Class ITerminated

Regard Dressing change kit, Item Number 800026006

ROi CPS LLC

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

November 20, 2023 · DeviceView details →
Class ITerminated

Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system

Asensus Surgical Inc

Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.

September 15, 2023 · DeviceView details →
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 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 →
Class ITerminated

Anesthesia Circuit Kit Coax 1, MP02730

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 (N) 180, MP00353

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 →
← PreviousPage 1 of 50Next →