🏥 Medical Devices Class I - Dangerous
Products do not meet a tensile strength specification
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
🏥 Medical Devices Class I - Dangerous
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Potential breakage of the endoscope s insertion tube bending section during surgical procedures
Uretero-reno fiberscope URF-P6RP6
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Breakage of the endoscope's insertion tube bending section during surgical procedures.
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
Life Technologies
🏥 Medical Devices Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
Life Technologies
🏥 Medical Devices Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
🏥 Medical Devices Class I - Dangerous
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
🏥 Medical Devices Class I - Dangerous
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
🏥 Medical Devices Class I - Dangerous
Products do not meet a tensile strength specification
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
🏥 Medical Devices Class I - Dangerous
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
Uretero-reno fiberscope URF-P6
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Breakage of the endoscope's insertion tube bending section during surgical procedures.
🏥 Medical Devices Class I - Dangerous
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Life Technologies
🏥 Medical Devices Class I - Dangerous
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.