Instrumentation Laboratory Co. and General Electric Co. (NYSE:GE) subsidiary Vital Signs Devices Inc. are undergoing Class 1 recalls for medical devices.

Instrumentation Lab’s "urgent field safety notification," issued earlier this month for its blood analyzer cartridges, was upgraded to a Class 1 recall by the FDA, the most serious type of recall issued in situations with a reasonable probability of serious adverse consequences or death.

The Bedford, Mass.-based company’s GEM Premier 4000 PAK cartridges, used to analyze whole blood samples at the point of care in a clinical setting or in a lab, were found to have error rates in excess of the allowable margins for assessment of blood potassium levels.

"Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death," according to the FDA recall. The cartridges were manufactured and sold from May 2006 up until this month, according to a release.

Vital Signs’ voluntary worldwide field corrective action for its hygroscopic condenser humidifier/anesthesia breathing circuit got a Class 1 bump by the FDA over concerns that the devices may have an occlusion that prevents sufficient oxygen from reaching the patient.

The affected units were manufactured between Jan. and April 2011.