Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Medtronic Vascular Galway
Class I - Dangerous
Stylette removal difficulties on the Euphora and Solarice products.
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Medtronic Vascular Galway
Class I - Dangerous
Stylette removal difficulties on the Euphora and Solarice products.
The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Class I - Dangerous
Fujifilm is conducting a corrective action due to an FDA inspection.
Class I - Dangerous
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
Class I - Dangerous
Software discrepancy of not showing all the EE constants, when the screen is filled.
Presence of loose polypropylene foreign matter above release specification.
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Class I - Dangerous
Software discrepancy of not showing all the EE constants, when the screen is filled.
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Leonhard Lang Medizintechnik GmbH
Class I - Dangerous
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Class I - Dangerous
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.