Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
CORNEAT VISION
Class I - Dangerous
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Class I - Dangerous
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Class I - Dangerous
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Potential for the lid of the catheter connector to be in the incorrect position.
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
CORNEAT VISION
Class I - Dangerous
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Class I - Dangerous
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
Class I - Dangerous
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Beckman Coulter
Class I - Dangerous
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Fresenius Medical Care Holdings
Class I - Dangerous
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare Americas
Class I - Dangerous
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Class I - Dangerous
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.