Devices were delivered without the required dry ice.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Philips North America
Class I - Dangerous
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class I - Dangerous
Devices were delivered without the required dry ice.
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
Moller Vital
Class I - Dangerous
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
M200 Fall Monitoring System
Stanley Security Solutions
Class I - Dangerous
Damaged capacitor on the printed circuit board.
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Becton Dickinson &
Class I - Dangerous
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
Class I - Dangerous
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Class I - Dangerous
Devices were delivered without the required dry ice.
Potential performance issues in the Alinity-ci software version 2.5.1
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Devices were delivered without the required dry ice.
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Philips North America
Class I - Dangerous
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Philips North America
Class I - Dangerous
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Compass Health Brands (Corporate Office)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)