Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
All Recalls
95,089 total recalls in our database
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Pride Mobility Products
The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.
All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Aesculap Implant Systems
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Endotoxin values from testing of retains slightly exceeded the established specification.
The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
Potential contamination with B. cepacia.
During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.
Snowmobiles
Arctic Cat Inc., of Thief River Falls, Minn.
The fuel tank can crack and fuel can leak into the engine compartment, posing a fire hazard.
Cynthia dressers
Unknown Manufacturer
The recalled chests are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children.
Bad Boy off-road utility vehicles
Textron Specialized Vehicles, Inc., of Augusta, Georgia
The vehicles lack seat belts, posing a risk of serious injury or death to the operator and passengers in the event of a vehicle accident.
Kids toy shovels and garden tool sets
Unknown Manufacturer
Excessive lead paint levels on the yellow shank and black blade on the shovel, and the black paint on the garden tool set violates the federal lead paint standard. In addition, the black plastic shovel handle and bag clip on the garden tool drawstring bag contain excessive lead content levels, a violation of the federal lead standard. Lead is toxic if ingested by young children and can cause adverse health effect.
Dunkin' Donuts Glass Tumblers
Unknown Manufacturer
The glass tumblers can crack or break, posing laceration and burn hazards.
Rock Salt Lamps
Unknown Manufacturer
The dimmer switch and/or outlet plug can overheat and ignite, posing shock and fire hazards.
Colon Therapy, bulk capsules
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
DHEA 25 mg, bulk capsules
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Oyster Dietary Supplement (unknown container size)
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Liver Energy, 100 capsules per bottle
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Arganine & Pine Bark, bulk capsules
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Esclewe Dietary Supplement (unknown container size)
Sunset Natural Products
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.