The edition · Emergency & Critical Care
FDA Class I recall of multi-dose epinephrine vials; restrictive oxygen after cardiac arrest showed no clear gain
A recall notice for epinephrine for resuscitation stock, a pooled analysis of oxygen targets after cardiac arrest, a paediatric CPR ventilation study, a cardiogenic shock substudy, and a small heatstroke cooling trial that argues against going to 35°C.
The edition in brief
The FDA lists a Class I recall of American Regent epinephrine injection 30 mg per 30 mL multiple-dose vials, dated 16 September 2026, for particulate matter, broken and leaking vials and lack of assurance of sterility; the status is ongoing. A meta-analysis of 11 randomised trials (4,136 adults) after cardiac arrest found restrictive oxygen targets no different from higher targets for mortality (RR 0.96, 95% CI 0.88 to 1.06) or unfavourable neurological outcome (RR 0.96, 95% CI 0.88 to 1.04), with more hypoxaemia (RR 1.65). In 234 paediatric in-hospital arrests the recommended ventilation rate of 20 to 30 per minute was not associated with survival (aRR 0.95); an exploratory finding that 26 or more breaths per minute was associated with survival in children under 8 needs confirmation. A DanGer Shock secondary analysis found a high baseline SYNTAX score predicted 180-day mortality, and the benefit of the microaxial pump was not modified by it. A pilot trial of 35 intubated adults with heatstroke found cooling to 35°C for 48 hours produced no difference in survival or function but more severe gastrointestinal injury (52.9% vs 0%) and arrhythmia (41.2% vs 11.1%).
FDA Class I recall of American Regent multi-dose epinephrine vials
Check whether you hold the recalled multi-dose epinephrine vials and quarantine them, and inspect every vial before use.
Restrictive oxygen targets after cardiac arrest showed no clear benefit in pooled trials
After resuscitation, titrate oxygen to a target saturation range and avoid hypoxaemia, as lower targets showed no outcome advantage.
Recommended CPR ventilation rates in children were not linked to survival
Keep to current paediatric resuscitation guidance, and note that ventilation rates in real arrests often differ from what is intended.
Coronary complexity predicted death in shock, but did not change the effect of the heart pump
Use SYNTAX complexity to inform prognosis in cardiogenic shock, and do not use it alone to decide on a mechanical support device.
Look at the vial before you draw up
Inspect every vial for particles and damage before drawing up, especially in a hurry.
Cooling heatstroke patients to 35°C showed more complications and no clear gain in a pilot
Cool heatstroke promptly to a normal core temperature, and avoid routinely holding patients at 35°C on the strength of this pilot's safety signals.
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