HeartSine SAM 350P, SAM 360P, SAM 450P Defibrillators Recall Over Membrane Tail Fault

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Due to a damaged (over stretched) membrane tail that causes an intermittent fault.", distributed worldwide - u.s. nationwide distribution including in the states of ak, al, az, ca, ct, dc, fl, ga, hi, ia, id, il, in, ks, ky, ma, md, me mi, mn, nc, nj, nm, nv, ny, oh, ok, or, pa, sd,tn, tx, ut, va, wa, wi, wv and wy. the countries of argentina, australia, brazil, canada, chile, colombia, hong kong, indonesia, israel, japan, malaysia, netherlands, philippines, poland, singapore, south korea, taiwan, thailand and united kingdom.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, medical-device.