Direxion and Direxion HI-FLO Microcatheters by Boston Scientific Corporation
A manufacturing issue may cause difficulty withdrawing the device from the carrier hoop. It may also…
CareIntellect Perinatal by GE Medical Systems Information Technologies Inc.
The system may lose monitoring information and clear active patient monitoring alarms when system connectivity is…
PMS-FAMPRIDINE 10 mg Tablet by Pharmascience Inc.
The affected lot of PMS-FAMPRIDINE 10 mg tablets may contain foreign material particles, which Health Canada…
BD Alaris Pump Module and subset of Compatible Pump Infusion Sets by BD Alaris (Carefusion 303, Inc. / BD Switzerland Sarl)
The BD Alaris Pump Module model 8100 may deliver less accurately with a subset of compatible…
Sarclisa by Sanofi-Aventis Canada Inc.
Affected vials may have been frozen during shipment, which can compromise the stability and effectiveness of…
Insulin pens and cartridges (Admelog, Admelog SoloSTAR, Apidra SoloSTAR, Lantus SoloSTAR, Toujeo DoubleSTAR, Toujeo SoloSTAR, Trurapi, Trurapi SoloSTAR) by Sanofi-Aventis Canada Inc.
Insulin that has been frozen during shipping may have reduced effectiveness even though it looks and…
PERMA-HAND™ Silk Suture by Ethicon LLC
The recalled lot was incorrectly manufactured with an unapproved alcohol-based tubing fluid, a solution of isopropyl…
Amplatzer™ Amulet™ Left Atrial Appendage Occluder by Abbott Medical
The device's instructions for use did not specifically identify the pulmonary artery as a structure to…
Inzone® Detachment System by Stryker Neurovascular
Stryker has observed that some devices may experience premature battery drain. Affected devices may not power…
Likorall™ Patient Lift Systems by Liko AB
A motor shaft breakage combined with reduced performance of the single fault safety (SFS) system can…
InterStim™ Systems (Percutaneous Extension and SureScan™ MRI Lead Kit) by Medtronic
Use of an incompatible lead or percutaneous extension, selected without regard to the intended system configuration,…
OmniaSecure MRI SureScan by Medtronic Inc.
Insufficient adhesive at the interface between the driveshaft assembly and the tip-to-ring spacer creates a weak…
Williams Cystoscopic Injection Needle by Cook, Incorporated (Cook Medical)
Cook Medical found that the female luer lock adapter on affected Williams Cystoscopic Injection Needles may…
Soprano diode laser hair removal systems and diode laser therapy systems by Soprano (counterfeit, falsely attributed to Beijing Perfectlaser Technology Co., Ltd.)
The counterfeit devices carry a falsified medical device licence, falsely presenting them as authorized medical devices…
Oxalate Reagent Kit (Oxalate Reagent B) by Trinity Biotech PLC
The affected lot can produce a negative bias and under-recovery of oxalate values, meaning test results…
RAPICIDE™ PA High Level Disinfectant by Medivators Inc. (STERIS)
Certain Part A bottles may bulge or swell if the cap's built-in vent becomes blocked, trapping…
IntelliSpace Critical Care And Anesthesia by Philips Medizin Systeme Boblingen Gmbh
A software defect in ICCA versions J.06.01 and J.06.02 can produce incorrect Intake Totals, Output Totals,…
NDI Passive Spheres™ by Northern Digital Inc.
Variation in the reflective coating on certain sterile lots may cause the navigation system's optical cameras…
Easymulti Stress (Men) capsules by Platinum Naturals Ltd.
Affected lots are labelled with the incorrect amount of Vitamin B6, a medicinal ingredient in the…
X10 Natural Enhancement Supplement by A&P Creations LLC (X10)
The product was found to contain undeclared sildenafil and tadalafil, the active ingredients in the prescription…
