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Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc. Recalls

All product recalls associated with Edwards Lifesciences Research Medical, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 17581–17600 of 21320 recalls

Edwards Lifesciences Research Medical, Inc.: CardioVations Ethicon, a Johnson and Johnson company, End...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDANov 26, 2008AL, AK, CA +32 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences CardioVations, EndoClamp aortic cath...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDANov 26, 2008AL, AK, CA +32 more• Edwards Lifesciences Research Medical, Inc.

Boston Scientific Corp: RF Ablation System Foot Switch. (Can be used with Boston...

Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.

1...878 879880881 882...1066

Page 880 of 1066Next

FDA

Nov 25, 2008

Nationwide

• Boston Scientific Corp

Fresenius Medical Care North America: CombiSet True Flow Series, Hemodialysis Blood Tubing with...

Port may crack and separate resulting in potential blood exposure/blood loss for the patient

FDANov 25, 2008Nationwide• Fresenius Medical Care North America

Stryker Howmedica Osteonics Corp.: Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot c...

Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.

FDANov 25, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Philips Medical Systems (Cleveland) Inc: Respiratory Gating System, Catalog #NPTA540, Model #4535 ...

A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.

FDANov 24, 2008PR• Philips Medical Systems (Cleveland) Inc

Stryker Howmedica Osteonics Corp.: AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. Thi...

Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

FDANov 24, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Lockin...

Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

FDANov 24, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Medtronic Cardiovascular: Medtronic COMPLETE SE Self Expanding Biliary Stent System...

Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.

FDANov 24, 2008AZ, CA, IN +5 more• Medtronic Cardiovascular

Becton Dickinson & Company: BD 1 ml Integra TB Syringe with Retracting Precision Glid...

Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.

FDANov 24, 2008FL, GA, KS +5 more• Becton Dickinson & Company

Boston Scientific Corporation: Flextome Cutting Balloon Device Over-the-Wire Delivery Sy...

Laceration Risk

For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural delay as users seek to explain the discr

FDANov 21, 2008Nationwide• Boston Scientific Corporation

Stryker Howmedica Osteonics Corp.: Restoration Modular Conical Distal Stem; Sterile, Titaniu...

Stryker became aware of a lot for lot mix up.

FDANov 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Varian Medical Systems Oncology Systems: Varian Medical Systems Eclipse treatment planning system,...

Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.

FDANov 21, 2008Nationwide• Varian Medical Systems Oncology Systems

Philips Medical Systems North America Co. Phillips: The device's marketing brochure states: "IntelliVue M3150...

Potential for Internal Sound Amplifier to malfunction which could delay treatment.

FDANov 21, 2008Nationwide• Philips Medical Systems North America Co. Phillips

GE Medical Systems, LLC: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging Sys...

GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag

FDANov 21, 2008CA, CO, FL +19 more• GE Medical Systems, LLC

Medtronic Xomed, Inc.: VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtroni...

Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

FDANov 21, 2008Nationwide• Medtronic Xomed, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Ins...

Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w

FDANov 20, 2008AL, AK, AZ +48 more• Smiths Medical MD, Inc.

Stryker Medical Div. of Stryker Corporation: Stryker Medical Stair-PRO Stair-Chair with wheels, patien...

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

FDANov 18, 2008Nationwide• Stryker Medical Div. of Stryker Corporation

Stryker Medical Div. of Stryker Corporation: Stryker Medical Stair-PRO Evacuation Chair civilian use s...

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

FDANov 18, 2008Nationwide• Stryker Medical Div. of Stryker Corporation

DiNotte Bicycle Light Batteries – Burn Hazard (2008)

Fire/Burn Risk

DiNotte Lighting Lithium-Ion battery with nylon bags are used with DiNotte 5W Li-Ion bicycle lights and DiNotte 3 LED police lights. The DiNotte logo is printed on the battery cable connector.

CPSCNov 18, 2008Nationwide• AA Portable Power Corp., of Richmond, Calif.