All Recalls

95,102 total recalls in our database

LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.

GE Medical Systems

🏥 Medical Devices Class I - Dangerous

GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.

Oct 23, 2015 Diagnostic Equipment Nationwide View Details →

Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.

Apr 25, 2006 Diagnostic Equipment View Details →

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

BioHorizons Implant Systems

🏥 Medical Devices Class I - Dangerous

An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

Oct 30, 2015 Implants & Prosthetics View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

AMS 4675 Angio Pack. For use in a general clinical procedure.

Windstone Medical Packaging

🏥 Medical Devices Class I - Dangerous

AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Nov 2, 2015 Other Medical Devices View Details →

Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.

Synthes (USA) Products

🏥 Medical Devices Class I - Dangerous

TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.

Nov 2, 2015 Other Medical Devices View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.

Zimmer

🏥 Medical Devices Class I - Dangerous

Complaints that the ratchet teeth of the tube are not latching onto the rod.

Nov 24, 2015 Implants & Prosthetics View Details →

LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →

One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

Sep 11, 2015 Other Medical Devices View Details →

Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

Valeant Pharmaceuticals North America

🏥 Medical Devices Class I - Dangerous

SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

Sep 14, 2015 Other Medical Devices View Details →

The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

Visicu

🏥 Medical Devices Class I - Dangerous

A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.

Mar 27, 2015 Other Medical Devices View Details →

AMS 4674 Custom Pack. For use in a general clinical procedure.

Windstone Medical Packaging

🏥 Medical Devices Class I - Dangerous

AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Nov 2, 2015 Other Medical Devices View Details →

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular

🏥 Medical Devices Class I - Dangerous

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Oct 21, 2015 Surgical Instruments Nationwide View Details →