Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Greiner Bio-One North America
Class I - Dangerous
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Class I - Dangerous
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Class I - Dangerous
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
Class I - Dangerous
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Merit Medical Systems
Class I - Dangerous
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Class I - Dangerous
CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
Class I - Dangerous
Sterility of device may be compromised due to lack of packaging integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity