American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Class I - Dangerous
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Class I - Dangerous
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
GE Medical Systems
Class I - Dangerous
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Class I - Dangerous
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Zimmer Manufacturing B.V.
Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Class I - Dangerous
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Class I - Dangerous
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Zimmer Manufacturing B.V.
Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
Class I - Dangerous
The product has potential to leak beyond their design specification.
Class I - Dangerous
The product has potential to leak beyond their design specification.
Class I - Dangerous
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.