FDA applicant

Shire Biologics, Inc.

San Diego, CA1 decision2002–20020 recalls

FDA records 1 decision for Shire Biologics, Inc. (San Diego, CA) in 2002: 1 510(k) clearance. All are in product code LHI (Set, I.V. Fluid Transfer). 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, general hospital panel, where it files most

How often FDA has decided Shire Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shire Biologics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Shire”

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

Shire Regenerative Medicine 2

Shire Biologics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Shire”