BDX · 10-Q · 2026Q2 · Full report

Regulatory Approval Milestones

BECTON DICKINSON & CO · 2026-08-06 · Importance 40 · Surprise 42 · In source text

BD remains subject to an amended FDA consent decree governing its U.S. infusion-pump operations, with the FDA continuing to review observations from a 2024 Form 483 and the company’s corrective action plan. The decree permits the FDA to order manufacturing or distribution cessation, product recalls and other actions, and allows damages of $15,000 per day per violation up to $15 million per year; BD had no accrual because it did not believe a loss was probable as of June 30, 2026. Separately, BD completed commitments under the November 2024 Dispensing Warning Letter, but potential FDA actions including seizure, injunctions and civil monetary penalties remain possible, and the company recorded a liability for estimated response and remediation costs.

Key facts

• BD may be required to pay damages of $15,000 per day per violation under the Consent Decree, up to $15 million per year. source
• BD received 510(k) clearance from the FDA for its updated BD Alaris Infusion System on July 21, 2023, and BD expects remediation or replacement of BD Alaris Infusion System devices in the U.S. market to be substantially complete this calendar year. source
• As of June 30, 2026, BD has received nine FDA clearances related to Specimen Management (formerly PAS) remaining commitments under the 2018 Warning Letter. source

Impact estimates