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Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic

Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic Recalls

All product recalls associated with Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic.

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Recall Summary

Total Recalls

1000

Past Year

583

Class I (Serious)

Most Recent

Dec 2025

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 9461–9480 of 10937 recalls

Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic: Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Man...

Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.

FDAMar 14, 2008PR• Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic

Merit Medical Systems, Inc.: CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K...

Component of convenience kit may not be sterile.

FDAMar 14, 2008OR, PA• Merit Medical Systems, Inc.

Philips Medical Systems North America Co. Phillips: AD 7 Patient table supplied with Allura Xper FD10 and All...

Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.

1...472 473474475 476...547

Page 474 of 547Next

FDAMar 14, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Varian Medical Systems, Inc.: VariSource CT/MR Ring & Tandem Applicator Set, catalog # ...

Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

FDAMar 12, 2008Nationwide• Varian Medical Systems, Inc.

Philips Medical Systems North America Co. Phillips: EasyVision RAD - Radiological Image Processor, software v...

Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).

FDAMar 10, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical Int...

Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.

FDAMar 10, 2008AL, AK, AZ +44 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Med...

Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.

FDAMar 7, 2008FL, GA, HI +6 more• Smiths Medical MD, Inc.

GE Medical Systems, LLC: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, ...

GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.

FDAMar 6, 2008MD, TX, VA• GE Medical Systems, LLC

GE Medical Systems, LLC: Innova 4100 / 4100 IQ, GE Healthcare, Waukesha, WI 53188 ...

FDAMar 6, 2008MD, TX, VA• GE Medical Systems, LLC

Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila: AxSYM Ultrasensitive hTSH II Master Calibrators Micropar...

High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.

FDAMar 6, 2008AZ, CA, CO +32 more• Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila

Kapp Surgical Instrument Inc: STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, L...

A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.

FDAMar 5, 2008Nationwide• Kapp Surgical Instrument Inc

Outlaw IRS ATVs (Polaris) – Rider Injury Risk (2008)

The recall involves select 2006-2008 Polaris "Outlaw" ATVs with Independent Rear Suspension (IRS). The affected models are: 2006 OUTLAW 500 "IRS" 2007 OUTLAW 500 "IRS" 2007 OUTLAW 525 "IRS" 2008 OUTLAW 525 "IRS" The model name is printed on decals located on either side of the fuel tank.

CPSCMar 4, 2008Nationwide• Polaris Industries Inc., of Medina, Minn.

Philips Medical Systems: CareVue Chart Release C ,Versions C.00.00 through C.00.06...

Medications prescribed for one patient were printed on the record of another patient.

FDAMar 4, 2008Nationwide• Philips Medical Systems

Philips Medical Systems: IntelliVue Clinical Information Portfolio Critical Care R...

Medications prescribed for one patient were printed on the record of another patient.

FDAMar 4, 2008Nationwide• Philips Medical Systems

Medtronic Neuromodulation: Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal...

Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

FDAMar 1, 2008FL, NC• Medtronic Neuromodulation

Med Tec Inc dba CIVCO Medical Solutions: Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, M...

Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.

FDAFeb 28, 2008Nationwide• Med Tec Inc dba CIVCO Medical Solutions

Med Tec Inc dba CIVCO Medical Solutions: Fiducial Markers (2mm spheres) Bone gold markers, Medical...

Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.

FDAFeb 28, 2008Nationwide• Med Tec Inc dba CIVCO Medical Solutions

Toshiba American Medical Systems Inc: Toshiba CT systems, Asteion and Aquilion, that are equipp...

The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.

FDAFeb 27, 2008Nationwide• Toshiba American Medical Systems Inc

Smiths Medical MD, Inc.: Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only,...

The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

FDAFeb 27, 2008AL, AZ, AR +43 more• Smiths Medical MD, Inc.

Smiths Medical PM, Inc.: BCI 3180 Oximeter - Patient monitoring medical device, M...

The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to

FDAFeb 27, 2008AL, AZ, CA +15 more• Smiths Medical PM, Inc.