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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

Remel

Class I - Dangerous

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

Jun 30, 2015 Other Medical Devices Nationwide View Details →

Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

Invacare

Class I - Dangerous

The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

Feb 2, 2015 Other Medical Devices Nationwide View Details →

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

Merit Medical Systems

Class I - Dangerous

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.

Jun 29, 2015 Surgical Instruments Nationwide View Details →

8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Synthes (USA) Products

Class I - Dangerous

The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

Jul 1, 2015 Surgical Instruments View Details →

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

Class I - Dangerous

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

Apr 15, 2015 Implants & Prosthetics View Details →

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

Trumpf Medical Systems

Class I - Dangerous

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Jul 27, 2015 Surgical Instruments Nationwide View Details →

Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

Cadence

Class I - Dangerous

Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.

Jul 9, 2015 Surgical Instruments Nationwide View Details →

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Abbott Point Of Care

Class I - Dangerous

Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

Jun 15, 2015 Diagnostic Equipment Nationwide View Details →

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

Advanced Sterilization Products

Class I - Dangerous

Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

Jul 17, 2015 Other Medical Devices Nationwide View Details →

Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212

Cadence

Class I - Dangerous

Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.

Jul 9, 2015 Surgical Instruments Nationwide View Details →

AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

Boston Scientific

Class I - Dangerous

AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Jul 31, 2015 Other Medical Devices View Details →

S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.

Aesculap

Class I - Dangerous

A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.

Jul 7, 2015 Other Medical Devices Nationwide View Details →

EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.

Medtronic Cardiovascular Surgery-the Heart Valve Division

Class I - Dangerous

Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

Jul 15, 2015 Infusion Pumps Nationwide View Details →

Beacon Tip Royal Flush Plus High-Flow 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

Class I - Dangerous

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.

Jul 2, 2015 Surgical Instruments Nationwide View Details →

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA

Class I - Dangerous

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Jun 29, 2015 Diagnostic Equipment Nationwide View Details →