Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
C.R. Bard
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Class I - Dangerous
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Aspirated Cyto-Histological Biopsy needle
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Bone Marrow Transplantation biopsy needle
M.D.L. S.r.l.
Class I - Dangerous
Sterility assurance may be compromised.
Class I - Dangerous
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Class I - Dangerous
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery
Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery
Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery
Class I - Dangerous
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
C.R. Bard
Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
SIGHT DIAGNOSTICS
Class I - Dangerous
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Greiner Bio-One North America
Class I - Dangerous
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.