Recall Z-0139-2027— Becton Dickinson & Co.

Name: FDA recall Z-0139-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-13

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2026-08-13. It names one FDA 510(k) clearance: K181665. Product: BD Phoenix Panel NMIC-312. Catalog Number: 449082.. Reason: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-13
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K181665 — BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company·cleared 2018-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Phoenix Panel NMIC-312. Catalog Number: 449082.

Reason for recall

Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

Data sourced from openFDA. This site is unofficial and independent of the FDA.