Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
Class I - Dangerous
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Beckman Coulter
Class I - Dangerous
Missing splash guard which may expose users to hazardous materials. .
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Bio-Rad Laboratories
Class I - Dangerous
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Class I - Dangerous
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
NOX MEDICAL
Class I - Dangerous
Error in the device firmware results in the inaccurate detection of device position.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class I - Dangerous
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.