🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
ProxiDiagnost N90, UDI 706100
Philips North America
🏥 Medical Devices Class I - Dangerous
The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.
🏥 Medical Devices Class I - Dangerous
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
🏥 Medical Devices Class I - Dangerous
Potential disconnection of tubing set.
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Incorrect Peel-Apart Introducer Sheath in Kit.
System, Tomography Computed Emmission
GE Healthcare
🏥 Medical Devices Class I - Dangerous
GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
🏥 Medical Devices Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
🏥 Medical Devices Class I - Dangerous
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
🏥 Medical Devices Class I - Dangerous
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible