Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
All Recalls
95,025 total recalls in our database
HEMO-10 Hemospray Endoscopic Hemostat
Wilson-Cook Medical
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
BioFinest Wintergreen Essential Oil
Unknown Manufacturer
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Leviton 50 ampere, non-NEMA electrical connectors, plugs, receptacles and inlets
Unknown Manufacturer
The electrical connection devices can have mislabeled terminal markings, posing an electrical shock hazard.
LUS Hair Dryers & Diffusers
Unknown Manufacturer
The hair dryers do not have an immersion protection device, posing an electrocution or shock hazard if the dryer falls into water when plugged in.
Dr. Mercola Wintergreen Essential Oil
LiquiFab, of Canada
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Eiji Essentials Wintergreen Essential Oil
Unknown Manufacturer
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 Capsules
CT Health Solutions
Due to different color of powder in capsules. Firm's evaluation determined product low potency.
Undeclared sulfites in product label.
Salmonella
Undeclared sulfites in product label.
Firm discovered that peanuts were included in mixed nut mix but not declared in labeling.
Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Lack of Processing Control
Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Lack of Processing Control
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Aurobindo Pharma USA
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Lack of Processing Control
Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Lack of Processing Control
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.