Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Autolube-III Product Usage: Pneumatic system
The Anspach Effort
Class I - Dangerous
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Omega Incline Platform Lift
Savaria Concord Lifts
Class I - Dangerous
Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Stryker Instruments Div. of Stryker
Class I - Dangerous
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
SmartSite Add-On Bag Access Device, Model No. 10013365
CareFusion 303
Class I - Dangerous
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Savaria Concord Lifts
Class I - Dangerous
Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
Class I - Dangerous
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Software version 4.44A utilized on the BD MAX System
BD LIFE SCIENCES
Class I - Dangerous
The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Beckman Coulter
Class I - Dangerous
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
BD Viper LT software, version 3.00H
Bd Diagnostic
Class I - Dangerous
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
Class I - Dangerous
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Smith & Nephew
Class I - Dangerous
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Class I - Dangerous
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Proteus 235, Proton Therapy System
Ion Beam Applications S.A.
Class I - Dangerous
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Instradent USA
Class I - Dangerous
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
Class I - Dangerous
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Class I - Dangerous
Customer reports of the device handset continuing to operate after release of the activation button.