95,075 total recalls in our database
Stryker Instruments Div. of Stryker
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Integra LifeSciences
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Siemens Healthcare Diagnostics
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Stryker Instruments Div. of Stryker
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Medtronic Vascular
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
A potential commingle that could result in the product in the package not matching the product on the outer label.
Accelerate Diagnostics
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Ace Surgical Supply Co.
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Stryker Instruments Div. of Stryker
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Zimmer Biomet
Potential failure of sterile packaging seal.
Stryker Instruments Div. of Stryker
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Diagnostic Hybrids
A component of the kit was found to contain bacterial contamination.
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Zimmer Biomet
Potential failure of sterile packaging seal.
Zimmer Biomet
Potential failure of sterile packaging seal.