A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
All Recalls
95,102 total recalls in our database
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Bard Access Systems
Bard Access Systems is recalling marketing brochures for the PowerPICCΒΏ and PowerPICCΒΏ SOLOΒΏ catheters due to incorrect indication for use contained in the brochure.
The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
Becton, Dickinson and Company, BD Biosciences
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Bien Air Dental SA
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Zien Medical Technologies
Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
Resource Optimization & Innovation
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Millennium Outdoors Fixed Position Tree stands
Unknown Manufacturer
The seat on the tree stand can bend in a downward angle, posing a fall hazard to the user.
Riding lawn mowers
Shivvers Manufacturing Inc., of Corydon, Iowa
The gas cap threads do not align with threads of the fuel tanks opening, which can allow fuel to leak, posing a fire hazard.
Pizza wheel pizza cutters
Calphalon Corporation, of Atlanta. Ga.
The handle of the pizza cutter can detach during use, posing a laceration hazard.
Pacifier clips
Unknown Manufacturer
The "D" ring on the pacifier clip can break, allowing beads to detach, posing a choking hazard.
Sandals
Unknown Manufacturer
The metal shank can dislodge and break through bottom of the outsole, posing a fall hazard.
Rattan Arm Chairs
Unknown Manufacturer
The chair may tip or slide backward, posing a fall hazard to consumers.