iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers by Beckman Coulter Ireland, Inc.
A structurally compromised rinse-line check valve may allow fluid to migrate internally within the analyzers. This…
Aisys CS2 and Carestation Anesthesia Systems by Datex-Ohmeda, Inc.
Certain electronic gas mixer assemblies in the affected anesthesia machines can automatically transition to Alternate O2…
OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml) by OPTIRAY
The vials contain particulate matter including polyethylene and other plastic materials, stainless steel and glass, which…
Azurion Systems by Philips Medical Systems Nederland
Software issues may cause image quality degradation or loss of geometry movements, which can lead to…
HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane Tail by Heartsine Technologies, Ltd.
A faulty internal component called the membrane tail can cause an intermittent fault at any point…
HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P by Heartsine Technologies, Ltd.
Affected devices were distributed without a required maintenance supplement containing periodic maintenance instructions that serve as…
Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. by Gas-X / Haleon
The softgels may be contaminated with a diluted propylene glycol-based coolant that leaked from a machine…
DCA Vantage® HbA1c (DX Claim) by Siemens Healthcare Diagnostics Inc.
A manufacturing defect can cause the buffer pull-tab in a small subset of cartridges to delaminate,…
Lidolog Kit (Lidocaine HCL Injection, USP, 2%) by Enovachem Pharmaceuticals
The product label wrap covers the barcode, preventing proper scanning during dispensing. This could lead to…
Zen Principle Moringa Leaf Powder Capsules by Zen Principle
The product may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal…
Presource ®Kits containing Teleflex Pilling® Wecksorb Neurosponge by Cardinal Health 200, LLC (also trading as Cardinal Health) / Teleflex Pilling
The affected Wecksorb Neurosponges may contain out-of-specification or potentially out-of-specification levels of endotoxin. Exposure during surgical…
Leoni Plus by Lowenstein Medical Se & Co. Kg
An electronic component inside the Leoni Plus device may overheat internally. This could lead to device…
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton by BD (Becton, Dickinson and Company) / CareFusion
Affected applicators may have an open or incomplete seal on the packaging, which could compromise the…
Apo-Tiotropium 18 mcg Capsules by Apotex Inc.
The particle size in the affected lots did not meet product specifications, which could affect how…
Fexofenadine Hydrochloride Tablets, USP 180 mg by Ohm Laboratories Inc (Sun Pharmaceutical Industries Inc)
The affected tablets failed impurities and degradation specifications, meaning the product may not meet required purity…
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g by Padagis
Testing revealed the cream is subpotent, meaning it may contain less active ingredient than required. This…
TAVNEOS (avacopan) capsules, 10 mg by Otsuka Canada Pharmaceutical Inc.
A key clinical trial used to support TAVNEOS's original authorization, the ADVOCATE trial, has significant data…
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial by Hikma / THYMOORGAN PHARMAZIE GmbH
The product was stored at controlled room temperature instead of being refrigerated as required, which may…
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial by Lupin Pharmaceuticals, Inc.
The syringe in the kit failed a Gliding Force functionality test, meaning the plunger may not…
Vista MAX Dietary Supplement, 90 Capsules by Vision of Health
Vista MAX contains undeclared Yellow #5, a color additive not listed on the product label. Consumers…
