95,114 total recalls in our database
Pro Numb Tattoo Numbing Spray
cGMP deviations
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Medline Industries
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Philips North America
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Philips North America
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Intuitive Surgical
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.