Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 433–444 of 1,125 recalls
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs).…
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery.…
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery.…
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Potential for microbial contamination.
Fungal contamination of affected lot with Parengyodontium album.
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups.…
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigato…
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigato…
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigato…