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Recall · EMS
An AED cabinet on a wall in Falkland, Scotland. The unit shown is not a HeartSine device. Photo: Bill Kasman / CC BY-SA 2.0
The newest, reported by the FDA on Oct. 7, covers 31,834 public-access defibrillators that shipped without a supplement adding a check every three months.
The report covers a death in Coconino County in July 2025. Plague in the lungs is the only form that spreads person to person.
Five new reports from the 2025 Youth Risk Behavior Survey were published today, covering mental health, diet, substance use and heart health.
Saline, lactated Ringer's and 70% dextrose. Particles named include fiberglass, iron oxide and stainless steel.
What changed in medicine, public health and EMS overnight, before your shift starts. Add alerts for recalls the day the FDA posts them.
Recalls, protocols, research and the data behind the job, written for the people who run the calls.
Two recalls opened July 27 cover 31,834 and 11,912 units.
MedicationsAmerican Regent, three lots, Class I. FDA report Sept. 16.
Equipment168,069 devices worldwide. Interfacility and home-vent calls take note.
Photo: William B. Grice / CC BY-SA 4.0, converted to black and white
| FDA report | Class | Product | Why | Quantity |
|---|---|---|---|---|
| Oct 7 | III | HeartSine samaritan PAD 350P, 360P, 450P | Shipped without the required Maintenance Supplement | 31,834 |
| Sep 23 | I | Thyroid Tablets USP, ½ grain (Vitruvias) | Superpotent drug | 1,955 bottles |
| Sep 16 | I | Epinephrine Injection 1 mg/mL, 30 mL multiple-dose vial (American Regent) | Particulate matter; lack of sterility assurance; broken and leaking vials | 31,935 vials |
| Sep 16 | I | 0.9% Sodium Chloride 100 mL (B. Braun) | Particulate matter | 201,472 |
| Sep 16 | I | Dextrose Injection 70%, 2,000 mL (Baxter) | Stainless steel particles | 606 bags |
| Sep 16 | II | HeartSine SAM 350P, 360P, 450P | Over-stretched membrane tail causes an intermittent fault | 11,912 |
| Sep 9 | I | 0.9% Sodium Chloride 500 mL VIAFLEX (Baxter) | Fiberglass particles | 145,464 bags |
| Sep 2 | I | Lactated Ringer's 1,000 mL EXCEL (B. Braun) | Particulate matter | 23,688 bags |
| Aug 5 | I | ResMed Astral 100/150 ventilator | Capacitor leak can damage the charger chip and interrupt ventilation | 168,069 |
Class I is the most serious: a reasonable chance of serious harm or death. Dates are when the FDA posted each recall to its enforcement report, not when the company started it.