M. Ibrahim Waseem connects FDA-flagged medical device manufacturers with quality-system remediation operators — because the response letter is only the starting gun.
Public FDA enforcement and recall records, updated as they publish — this is the market I watch.
- →ZIIP, Inc. — CGMP/QSR medical-device warning letter posted 14 July 2026
- →Nihon Kohden Digital Health Solutions — device warning letter citing adulteration, misbranding, and missing clearance; posted 14 July 2026
- →Baxter corrected Volera positive-pressure breathing devices; FDA posted 14 July 2026
- →Medtronic removed Harmony catheter delivery systems; FDA posted 13 July 2026
Sourced from FDA Warning Letters and Medical Device Recalls & Early Alerts.
Updated 17 July 2026 · mohd.ibrahim.waseem@gmail.com if any of these are yours
No deal to point at yet — so here’s exactly what I put in motion.
- Warning-letter recipient → remediation operator When the response deadline starts moving, I route the manufacturer to a quality operator who can turn the letter into a workable remediation programme.
- Quality-system gap → reinspection-ready rebuild The durable work begins after the reply: CAPA, documentation, training, and the systems that must hold when FDA returns.
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.
What I see in this market that outsiders miss.