FDA applicant

Fenwal Laboratories

Round Lake, IL1 decision1986–19860 recalls

FDA records 1 decision for Fenwal Laboratories (Round Lake, IL) in 1986: 1 510(k) clearance. All are in product code KJA (Flask, Tissue Culture). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Fenwal Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fenwal Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fenwal Laboratories by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Fenwal”

FDA records each applicant name separately; these may or may not be the same firm.

Fenwal, Inc. 4

Fenwal Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Fenwal”