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 21–40 of 1,000 recalls

Class ITerminated

VentStar breathing bag Set (P) 110, MP00384

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 HEPA, MP17102

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 230, MP03376

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 Bag Set (N) 110, MP00383

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 w/oLL, MP00362

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 (P) 150, MP00379

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 Coax 180, MP03375

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

BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

Avanos Medical, Inc.

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

February 3, 2023 · DeviceView details →
Class ITerminated

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

Avanos Medical, Inc.

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

February 3, 2023 · DeviceView details →
Class ITerminated

SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.

Cardiac Assist, Inc

A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

December 5, 2022 · DeviceView details →
Class ITerminated

RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.

Emergent Protective Products USA Inc

Complaints of leaking packets were received.

November 24, 2022 · DeviceView details →
Class ITerminated

Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

ARROW INTERNATIONAL Inc.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

October 27, 2022 · DeviceView details →
Class ITerminated

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

ARROW INTERNATIONAL Inc.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

October 27, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
Class ITerminated

Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

October 20, 2022 · DeviceView details →
← PreviousPage 2 of 50Next →