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…
Lipofit Extreme Fat Burner 2.0 by Lipofit
The AM tablets contained undeclared fluoxetine, a prescription antidepressant, while the PM tablets contained undeclared 2,4-dinitrophenol…
Carestation 850 by Datex-Ohmeda, Inc.
The Carestation 850 and 850C anesthesia systems can shut down unexpectedly when AC mains power is…
0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun
Testing found particulate matter identified as zinc oxide inside the saline containers. Administering the contaminated product…
Cardinal Health Gynaecology Robotics and Endoscopy Packs by Cardinal Health
The recalled packs contain a StrykeFlow PS handpiece component linked to an increased number of complaints…
Automated Impella Controller (AIC) by Abiomed Inc.
A failing purge flag component can prevent the controller from correctly recognizing the purge cassette, most…
MD Wipe Outz Numbing Tattoo Wipes by Diamond Wipes International, Inc. / MD Wipe Outz
The wipes contain lidocaine, a topical anesthetic that by law must be sold in child-resistant packaging.…
Med-Rx Medication/Primary Solution Administration Kit by Canadian Hospital Specialties Ltd. (CHS)
Discoloration has been found in the drip chamber of the IV sets used in these administration…
BIOFIRE® Joint Infection Panel – 30 Pack by Biofire Diagnostics, LLC.
Affected lots can produce false positive results for KPC, a gene linked to carbapenemase-producing organisms, due…
CARESCAPE Central Station by Ge Medical Systems Information Technologies Inc. (GE Healthcare)
The CARESCAPE Central Station (CSCS) v3.0.x may fail to resume patient monitoring for at least 3…
0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container by Baxter
Intravenous administration of solution containing fiberglass particulate matter may cause blockage and clotting in blood vessels,…
Cyanosure DermaV Laser System by Cynosure Lutronic Technology Corporation
Spark and loud noise events during vascular laser treatment at the 1064 nm wavelength, particularly at…
Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container by Baxter
The solution may contain fiberglass particulate matter. If not caught by in-line filtration during apheresis use,…
70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container by Baxter
The recalled solution may contain stainless steel particulate matter, which if administered intravenously can cause blockage…
Percutaneous Insertion Kit and Dilator Sets by Maquet Cardiopulmonary GmbH
Packaging used for the Percutaneous Insertion Kit and Dilator Sets may not consistently maintain sterile barrier…
Twins Herbal Idakole and Twins Herbal Pelorie by Twins Herbal
The products contain undeclared sildenafil, a prescription-only drug that can dangerously interact with nitrate medications used…
