95,050 total recalls in our database
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
An error in the assignment of the control range pH in Blood Gas Control
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
On-X Valve was mislabeled with the incorrect serial number.
Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Breach in the sterile barrier pouch may compromise sterility of the device.
Keystone Dental
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Keystone Dental
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.
Breach in the sterile barrier pouch may compromise sterility of the device.
Unknown Manufacturer
The wireless chargers can overheat, posing a burn hazard.
Unknown Manufacturer
The bicycle's fork legs can break, posing an injury hazard.
Pinghu Tianli Garment Co., LTD, of Jiaxing, China
The jacket's snaps can detach, posing a choking hazard to young children.
Amerequip Corporation, of Kiel, Wis.
The Attachment Kits are missing the product Operator's Manual which details proper attachment and use of the product, posing an injury hazard.
Ocean Reef Inc., of San Marcos, Calif.
The diving mask regulator can cause restricted airflow, posing an injury hazard to divers.
Shenzhen Casun Technology Co. Ltd., of China
The charger can overheat while recharging, posing a fire hazard.