Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
All Recalls
95,075 total recalls in our database
VALITUDE X4 CRT-P Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
🏥 Medical Devices Class I - Dangerous
There was a case that the swivel arm went down unintentionally when it was moved up/down.
ESSENTIO EL DR Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
VISIONIST X4 CRT-P Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
🏥 Medical Devices Class I - Dangerous
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
PROPONENT VDD SL Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
ALTRUA 2 DR Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
🏥 Medical Devices Class I - Dangerous
Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
🏥 Medical Devices Class I - Dangerous
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
ESSENTIO MRI DR Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Persona Partial Knee System, Size 8, Finishing Guide
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
PROPONENT MRI Pacemaker
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Fidget spinner keychains
Fashion Accessory Bazaar, of New York, N.Y.
🏠 Consumer Products Class II - Moderate
The center post on the fidget spinner can become loose or fall out, posing a choking hazard.
Panasonic 55-inch flat screen LED/LCD televisions with tabletop swivel stands
Panasonic Corporation of North America, of Newark, N.J.
🏠 Consumer Products Class I - Dangerous
The mounting screws that connect the swivel stand to the television can come loose and cause the television to tip over and fall off the stand unexpectedly, posing serious tip-over and entrapment hazards that can result in injuries or death to children.
Multipro Baby Cradle N Swings
Multipro Limited, of India
🏠 Consumer Products Class II - Moderate
The bassinets fail to meet the mandatory federal safety standard for bassinets and cradles, posing fall and entrapment hazards to babies.