Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
28,992 detailed records are currently available in this category.
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United…
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this…
It was discovered that both the new device and the predicate device failed to comply with performance standard.
There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the…
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the…
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for…
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United…
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the…
Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2…
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the…
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the…
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for…
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United…
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
