95,025 total recalls in our database
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Microbiologics
Real-time shelf life testing failed at 24 months
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Brasseler USA, Medical L.L.C.
One lot of product was distributed in unsealed packaging
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Orthosoft, Inc.
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
Microbiologics
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Stryker Leibinger GmbH & Co. KG
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Microbiologics
Real-time shelf life testing failed at 24 months
Shimadzu Medical Systems
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
American Honda Motor Co. Inc., of Timmonsville, South Carolina
The vehicle's intake funnel band screw can loosen and enter the engine through the intake funnel and cause sudden engine failure. If this occurs, it could result in a loss of control, increasing the risk of a crash or injury.
Unknown Manufacturer
The maracas can break or become unscrewed and release the metal beads inside, posing choking and suffocation hazards to young children.
Unknown Manufacturer
The ranges can tip over when a heavy weight is placed on an open oven door and the anti-tip-over bracket is not secured to the wall or floor, posing a tip-over hazard and risk of burn injuries from hot food or liquids in cookware.
Unknown Manufacturer
The flashlights can be turned on inadvertently and overheat while stored in the holster or a consumer's pocket, posing a burn hazard to consumers.
Unknown Manufacturer
Fuel can leak from the fuel tank vent onto hot components when the snowmobiles are on a tilt or flipped over, posing a fire hazard.