INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Canon Medical System, USA
🏥 Medical Devices Class I - Dangerous
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Medtronic Xomed
🏥 Medical Devices Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
🏥 Medical Devices Class I - Dangerous
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Medtronic Xomed
🏥 Medical Devices Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Oculus Optikgeraete GMBH
🏥 Medical Devices Class I - Dangerous
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
AIM-V Medium REF AV.200/500
OXFORD IMMUNOTEC
🏥 Medical Devices Class I - Dangerous
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Artis pheno- Model No. 10849000
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Oculus Optikgeraete GMBH
🏥 Medical Devices Class I - Dangerous
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
🏥 Medical Devices Class I - Dangerous
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Qiagen Sciences
🏥 Medical Devices Class I - Dangerous
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Medtronic Xomed
🏥 Medical Devices Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
🏥 Medical Devices Class I - Dangerous
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
🏥 Medical Devices Class I - Dangerous
Some of the devices did not pass fatigue testing.
🏥 Medical Devices Class I - Dangerous
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Otter MOMO Children's Sandals
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The inner layer of the recalled sandals contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
Sun Joe Cordless Lawn Mowers models 24V-X2-17LM and 24V-X2-17LM-CT
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The mower blade can detach unexpectedly, posing a laceration hazard.
Novogratz brand Outdoor Metal Hanging Chairs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The hanging chair can tip or fall over or the metal hook or chain suspending the chair can break when a consumer is seated in the chair, posing a fall hazard.
UPPAbaby All-Terrain RIDGE Jogging Strollers
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The stroller's rear disc brakes have openings that can cause amputation or laceration if a non-occupant child's fingertip gets caught in the openings while the stroller is in use.