FDA Medical Devices

FDA Medical Devices Recall Insight

PlainRecalls tracks 26,000 recall actions attributed to the FDA Medical Devices in our federal recall index. Across the full PlainRecalls database of 83,949 records spanning 1995 through 2026, FDA Medical Devices accounts for roughly 31.0% of all indexed recalls. The agency's stated scope — U.S. Food and Drug Administration — Medical device recalls — determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 520 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Looking at the 50 records on this page alone, the severity distribution skews toward 10 critical (Class I-equivalent) actions, 25 moderate recalls, and 15 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 48 disclose a unit count — the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Sep 3, 2025 to Sep 10, 2025, covering 24 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories — for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Medical Devices's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions — medical, automotive, or childcare — always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).