All Recalls

95,114 total recalls in our database

HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Nitinol Devices and Components

🏥 Medical Devices Class I - Dangerous

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

May 28, 2014 Diagnostic Equipment Nationwide View Details →

ANSPACHREF SP-4601-001mm Coarse Diamond Ball for Adjustable 25cm Mia AttachmentRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

SeaSpine

🏥 Medical Devices Class I - Dangerous

Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.

May 21, 2014 Implants & Prosthetics View Details →

Ingenia 3.0T, magnetic resonance imaging system.

Philips Medical Systems

🏥 Medical Devices Class I - Dangerous

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun 13, 2014 Diagnostic Equipment Nationwide View Details →

ANSPACHREF SP-4605-00Arthroscopic Suture Anchor assembly with Suture ThreaderRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF 98-0020Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture PullerRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHArthroscopic Knotless Suture AnchorRx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF 98-0048Custom Circular ePLUS-FPRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

Jun 2, 2014 Diagnostic Equipment Nationwide View Details →

SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

SteriGear

🏥 Medical Devices Class I - Dangerous

SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

Jan 11, 2011 Surgical Instruments Nationwide View Details →

ANSPACHREF 98-0019Modified MDA Tube with MA-D20 AttachmentRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

Ingenia 3.0T R5, magnetic resonance imaging system.

Philips Medical Systems

🏥 Medical Devices Class I - Dangerous

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun 13, 2014 Diagnostic Equipment Nationwide View Details →

ANSPACHREF 98-0034Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot PedalRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF SP-3014-004mm Fluted Ball for MRIRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Nitinol Devices and Components

🏥 Medical Devices Class I - Dangerous

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

May 28, 2014 Diagnostic Equipment Nationwide View Details →

ANSPACHeMax2 Lower Profile Foot PedalRx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF SP-3101-00Adjustable 25 Cm Mia Attachment, CustomRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHCustom MCA5-1SD with Extended ExposureRx Only*** This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

ANSPACHREF 98-0037Custom Device SC2102 with fast stop firmwareRx Only This device is intended to be used with Anspach Systems

The Anspach Effort

🏥 Medical Devices Class I - Dangerous

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Nov 28, 2012 Other Medical Devices View Details →

MAS Omni Immune PRO Controls

Microgenics

🏥 Medical Devices Class I - Dangerous

The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.

Dec 2, 2013 Other Medical Devices Nationwide View Details →