Ken connects device companies sitting on an active FDA recall with the supplier-quality and recall consultants who can actually close it — while the event is still public.
This is the market I watch.
366 device recalls from 123 firms in the last 60 days, 39 of them Class I. Pulled September 11, 2026.
Sourced from the openFDA device enforcement database, the FDA’s own recall record.
No deal to point at yet — so here’s exactly what I put in motion.
A Class I recall starts a clock the firm has never run before: FDA reporting, customer notification, effectiveness checks, and a root cause that has to hold up. I put them in front of someone who has closed one out and knows where these go wrong.
Kit packers and distributors get recalled for parts they did not make. Their exposure is in the supplier file, not the production line. I bring operators the firms who just found that out.
Building in the open. I’m working alongside myoProcess, a vetted B2B partner trusted across $1B+ in transactions, while I route my first introductions in this lane. My first closed match replaces this paragraph.