Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
🏥 Medical Devices Class I - Dangerous
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
🏥 Medical Devices Class I - Dangerous
The firm is distributing the Rejuvenator device without an approved 510(k).
Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t
🏥 Medical Devices Class I - Dangerous
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
🏥 Medical Devices Class I - Dangerous
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t
🏥 Medical Devices Class I - Dangerous
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
🏥 Medical Devices Class I - Dangerous
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
🏥 Medical Devices Class I - Dangerous
Product was distributed past its expiration date.
🏥 Medical Devices Class I - Dangerous
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
🏥 Medical Devices Class I - Dangerous
Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
Fiskars® 32-Inch Bypass Lopper Shears
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The lopper handles can break when attempting to cut branches, posing a risk of serious injury and laceration.
Bed bug heat treatment system
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The flexible, electrical conducting strip at the top of the heating element can break at the corners after multiple setups, posing an electrical fire hazard.
All-terrain vehicles
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
In hot environments or high elevations, the fuel cap can fail to vent properly, causing the fuel to heat up and pressure to build up in the tank. The pressure can cause the fuel tank to rupture or the fuel to boil out of the tank onto the operator or hot engine, resulting in burns to the operator or a fire.
Koala children's sandals with butterfly wings
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The butterfly wings on the children's sandals can rip and detach, posing a choking hazard to young children.
Zazou women's silk scarves
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The scarves fail to meet the federal flammability standard for wearing apparel and pose a risk of burn injury to consumers.
Boku Super Food 3.0, Product Sizes: 10 oz.
BoKU International
🍎 Food Class I - Dangerous
Boku is recalling Super Food because it may be contaminated with Salmonella.
Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
Supreme Distributors
🍎 Food Class I - Dangerous
Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage.