🏥 Medical Devices Class I - Dangerous
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
All Recalls
95,089 total recalls in our database
MEVION S250 Product Usage: Proton Radiation Therapy System
Mevion Medical Systems
🏥 Medical Devices Class I - Dangerous
Recovery of Incorrect Isocenter -operational change
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
🏥 Medical Devices Class I - Dangerous
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
🏥 Medical Devices Class I - Dangerous
Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The product label does not include the correct current rating.
Ingenuity CT Computed Tomography X-ray system, Model 728326
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The product label does not include the correct current rating.
🏥 Medical Devices Class I - Dangerous
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.