InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Biogenex Laboratories
Class I - Dangerous
Product was distributed without 510(k) approval.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Class I - Dangerous
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
Class I - Dangerous
Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.
Class I - Dangerous
The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Terumo Cardiovascular Systems
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Class I - Dangerous
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Terumo Cardiovascular Systems
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Class I - Dangerous
"Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".
Class I - Dangerous
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
ACL TOP (Base), automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
ACL TOP 700, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.