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.
26,155 detailed records are currently available in this category.
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Certain lots were mislabeled with incorrect product number.
Product with incorrect shelf life.
The titanium implant has the wrong article number laser marked on it.
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
User may suffer an electric shock when coming in contact with the exposed electronic components
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect…
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
Incorrect needle length and gage.
Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Product with incorrect shelf life.
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may…
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample…
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in…
Certain lots were mislabeled with incorrect product number.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect…
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
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.
