Medical equipment, implants, and diagnostic devices
Limacorporate S.p.A
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Stradis Medical, LLC
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Stradis Medical, LLC
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
Instrumentation Laboratory
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
GE Healthcare
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
There was an increase in complaints related to tip breaks and wobble/vibration.
Fort Defiance Industries
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
Smiths Medical ASD
Product may have been manufactured with an air filter assembled in an incorrect orientation.
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
National Distribution & Contracting
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Philips North America
Customers were not notified of previous recalls associated with various defibrillator models.
Abbott Molecular
There is a potential for false positive results.
Medtronic Sofamor Danek USA
Engraving on implants may not match what is listed on the pouch labels.
ELEKTA SOLUTIONS AB
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Centese
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.