🏥 Medical Devices Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
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95,064 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
Leica M525 F20 Surgical Microscope System
Leica Microsystems
🏥 Medical Devices Class I - Dangerous
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments Gmbh
🏥 Medical Devices Class I - Dangerous
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Pro-Med Instruments Gmbh
🏥 Medical Devices Class I - Dangerous
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
🏥 Medical Devices Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
🏥 Medical Devices Class I - Dangerous
Products are labeled with an incorrect expiration date
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
🏥 Medical Devices Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
🏥 Medical Devices Class I - Dangerous
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
🏥 Medical Devices Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
🏥 Medical Devices Class I - Dangerous
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
Ventana Medical Systems
🏥 Medical Devices Class I - Dangerous
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
🏥 Medical Devices Class I - Dangerous
There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Arrow International
🏥 Medical Devices Class I - Dangerous
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
🏥 Medical Devices Class I - Dangerous
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.