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.
21,924 detailed records are currently available in this category.
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Lack of sterility assurance for closed suction catheter systems
Potential for collimator to fall as a result of incorrect installation.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate…
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Lack of sterility assurance for closed suction catheter systems
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This…
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the…
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the…
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the…
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.
