Vortex Surgical Recalls Laser Probe Due to Smooth Passage Issues
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
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Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Cross Contamination with Other Products
Intuitive Surgical recalled 12 Da Vinci 5 surgical consoles on November 17, 2025. A software error may cause loss of user interface content on external monitors. Healthcare providers must stop using the devices immediately.
ETAC A/S recalled 64 units of Molift 2-point sling bars on November 17, 2025. A defect in the mounting bolt can lead to failure during use. This poses serious risks for users relying on the device for mobility assistance.
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Molift recalled 71 Mover 300 mobile hoists on November 17, 2025, due to a potential bolt failure. The defect can lead to limited mobility, posing a high risk to users. Affected models include M1501, M1502, M1504, among others.
Customer complaints of Pressio monitor rebooting.
ETAC A/S recalled 95 Molift Mover 205 devices due to a serious defect. The lifting bar bolt can break during use, posing a high risk of injury. Customers should stop using the product immediately and contact the company for further instructions.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lupin Pharmaceuticals recalled 32,736 vials of Ganirelix Acetate Injection on November 13, 2025. The recall follows the discovery of impurities in the drug. Consumers and healthcare providers should stop using the product immediately to avoid health risks.
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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