biQ-FEL 500 mL dietary supplement by A&P Creations LLC / biQ-FEL
The product contains undeclared sildenafil and tadalafil, the active ingredients in prescription drugs Viagra and Cialis.…
Organika® Lion's Mane Gummies; Organika® Reishi Gummies; Organika® Creatine Gummies by Organika
The affected gummies were manufactured at a foreign facility not listed on the company's Health Canada…
TZIELD, teplizumab for injection, 2 mg per 2 mL (1 mg/mL) for intravenous infusion by TZIELD (sanofi-aventis Canada Inc.)
TZIELD has been linked to serious and life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV)…
Glutathione 200mg/mL, Myer's Cocktail, and Tri-Immune Boost injectable vials by Centric Compounding
The recalled injectable products were compounded using a Glutathione API with elevated endotoxin levels, which can…
Centricity High Acuity Anesthesia by GE Healthcare (GE Healthcare IITS USA Corp)
The Centricity High Acuity Anesthesia system has two identified display and printout errors affecting order and…
Novo-Gesic Forte 500 mg (acetaminophen) by Teva Canada Limited
The recalled tablets may contain foreign material, specifically phenolic resin or epoxy, which are not intended…
Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer by Beckman Coulter, Inc.
A software issue may cause chemistry test results on plasma samples to silently revert from user-configured…
IMN Screws System Advanced Locking Screw by Stryker Gmbh
The recalled lot is mislabeled as containing a 57.5mm screw when it actually contains a 75mm…
Philips Ingenia, Achieva and Intera MR Systems by Philips Medical Systems Nederland B.V.
A software issue in Philips MR systems running versions R5 and R11 can cause the system…
Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. Versions by Philips Medical Systems Nederland B.V.
Air bubbles can form in the monoblock oil when systems sit too long between manufacture and…
Luna G3 APAP (Model LG3600) by BMC Medical Co., Ltd.
If the affected device operates simultaneously under high pressure, high respiratory rate, and high peak flow,…
Imager™ II Angiographic Catheter by Boston Scientific Corporation
The catheters were manufactured with reduced levels of stabilizing agents in the tip material, which can…
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive by W.L. Gore & Associates Inc
Equipment used in manufacturing operated outside its validated range, which could cause the distal tip to…
LIFEPAK ® 35 Monitor/Defibrillator by Physio-Control, Inc.
Certain printer and modem access port connectors may not be fully seated within the rear housing…
Business Pill and Branch Manager for Men by SUPPLX.com
FDA testing found dangerously high, undeclared levels of yohimbine in both products, which can cause severe…
Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi dose vial by American Regent, Inc.
Particulate matter identified as nylon, cellulosic material, acrylic, polyethylene and glass was found in the injection.…
Quantum PureFlow Standard Heat Exchanger High Flow by Spectrum Medical Srl
Blood-to-glycol leakage was identified in the heat exchanger during a surgical procedure. This may allow blood…
BiCOAG Hemostasis Probe by Gyrus Acmi, Inc (Olympus)
The affected probes may have been manufactured without the designated amount of adhesive at the rear…
LIFEPAK ® 35 Monitor/Defibrillator by Physio-Control, Inc. (Stryker)
The device may fail to display the 'CHECK RHYTHM / ECG Analysis Inconclusive' message when specific…
JAMP Temozolomide by JAMP Pharma Corporation
The active ingredient temozolomide was found to be out of specification during assay testing, meaning capsules…
