Industry Trends › Recalls
Class I Device Recall Trends
A Class I recall is the FDA's highest-severity classification, reasonable probability of serious injury or death. None of the 137 distinct recall events since July 2025 were FDA-mandated; every one was firm-initiated.
Recall Volume by Month
FY2026 Q4 (Jul–Sep 2026) shows 19 events in the openFDA records through October 21, 2026. Late postings can raise it.
Firms Recalled Before the FDA Required It
None of these 137 events waited for the FDA to force a recall. Each of these firms found a problem and acted before the FDA had to require it. A CAPA program aims for the same result.
What to check: a firm-initiated Class I recall is the same root-cause discipline as a CAPA, found before the FDA found it instead of after.
Recall Execution & RemediationSource: openFDA device enforcement records, Class I, deduplicated to distinct recall events (one event can span many product-code rows).
Repeat Filers
Repeat Filings and Root Cause Closure
Only 68 distinct firms account for these 137 events.
What to check: if your firm has filed more than one Class I recall in this window, confirm that the root cause was closed and not only the affected lot.
Assess Your Quality System
A confidential conversation is the fastest way to find out. No proposal required to start.
Contact Us