Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
All Recalls
95,114 total recalls in our database
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Colored contact lenses were distributed without FDA clearance.
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Colored contact lenses were distributed without FDA clearance.
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Colored contact lenses were distributed without FDA clearance.
There are reports of the suction catheter coming apart from the device assembly during use.
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Shanghai United Imaging Healthcare Co.
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Colored contact lenses were distributed without FDA clearance.
Breaking at the point of a welded joint
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co.
Colored contact lenses were distributed without FDA clearance.
Breaking at the point of a welded joint
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Moravian Star lights
Unknown Manufacturer
The lights lack adequate minimum wire size and overcurrent protection, posing fire and electrical shock hazards to consumers.
X-14® Mildew Stain Remover
Spartan Chemical Company Inc., of Maumee, Ohio
Pressure can build up inside the bottle and cause it to fall over and leak, posing a risk of skin irritation.
Bio Source Naturals Wintergreen and Birch Sweet Essential Oils
Bio Source Naturals, of New Boston, Mich.
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 products are not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Valor H5 gas fireplace
Miles Industries Ltd., of Canada
Delayed ignition due to pilot degradation can cause gas in the fireplace to accumulate prior to burner ignition. When ignition takes place, it can cause the glass window to shatter, posing burn and laceration hazards.
Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM
Cj Haide (Ningbo) Biotech Co.
complaint of metal fragments
Undeclared walnut. Carrot Cake Layered Cheesecake was incorrectly decorated as Red Velvet Layered Cheesecake and was mis-labeled. Finished product label does not declare walnut.
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.