Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official 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 781–800 of 1,000 recalls

Class ITerminated

Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

Cook Inc.

Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.

July 2, 2015 · DeviceView details →
Class ITerminated

Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

Elite Biomedical Solutions LLC

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

June 3, 2015 · Device
View details →
Class ITerminated

Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

Elite Biomedical Solutions LLC

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

June 3, 2015 · DeviceView details →
Class ITerminated

HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

Teleflex Medical

The double swivel connector may crack or separate on the endobronchial tube.

June 1, 2015 · DeviceView details →
Class ITerminated

HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.

Teleflex Medical

The double swivel connector may crack or separate on the endobronchial tube.

June 1, 2015 · DeviceView details →
Class ITerminated

HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

Teleflex Medical

The double swivel connector may crack or separate on the endobronchial tube.

June 1, 2015 · DeviceView details →
Class ITerminated

HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

Teleflex Medical

The double swivel connector may crack or separate on the endobronchial tube.

June 1, 2015 · DeviceView details →
Class ITerminated

M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Zimmer, Inc.

Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision

May 18, 2015 · DeviceView details →
Class ITerminated

Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.

Teleflex Medical

The intake port may be blocked which can cause the bag to fail to fill.

May 14, 2015 · DeviceView details →
Class ITerminated

SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.

Ethicon Endo-Surgery Inc

Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.

May 13, 2015 · DeviceView details →
Class ITerminated

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

May 8, 2015 · DeviceView details →
Class ITerminated

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

May 8, 2015 · DeviceView details →
Class ITerminated

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Synovis Surgical Innovations, Inc.

Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.

May 2, 2015 · DeviceView details →
Class ITerminated

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

Alcon Research, Ltd.

There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.

April 15, 2015 · DeviceView details →
Class ITerminated

CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

Carefusion 211 Inc dba Carefusion

A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

April 3, 2015 · DeviceView details →
Class ITerminated

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

Maquet Cardiovascular Us Sales, Llc

In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

April 2, 2015 · DeviceView details →
Class ITerminated

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

OriGen Biomedical, Inc.

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

March 30, 2015 · DeviceView details →
Class ITerminated

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

OriGen Biomedical, Inc.

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.

March 30, 2015 · DeviceView details →
Class ITerminated

TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

Laax, Inc.

Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

March 25, 2015 · DeviceView details →
Class ITerminated

TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

Laax, Inc.

Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

March 25, 2015 · DeviceView details →
← PreviousPage 40 of 50Next →