The Recall Desk
Agency classClass IIOur severity:Severity pendingFDA (Devices)·Z-0139-2027·Announced 2026-10-21

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

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Devices
Affected units
553,625

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (10)5349874(17)26 1209(30)0025(01)3 0382904490820
  • (10)6008828(17)26 1226(30)0025(01)3 0382904490820
  • (10)5350977(17)26 1228(30)0025(01)3 0382904490820
  • (10)6028392(17)27 0120(30)0025(01)3 0382904490820
  • (10)6034513(17)27 0131(30)0025(01)3 0382904490820
  • (10)6042998(17)27 0202(30)0025(01)3 0382904490820
  • (10)6042021(17)27 0203(30)0025(01)3 0382904490820
  • (10)6056431(17)27 0217(30)0025(01)3 0382904490820
  • (10)6069033(17)27 0309(30)0025(01)3 0382904490820
  • (10)6083447(17)27 0327(30)0025(01)3 0382904490820
  • (10)6098295(17)27 0330(30)0025(01)3 0382904490820
  • (10)6104811(17)27 0412(30)0025(01)3 0382904490820
  • (10)6104042(17)27 0419(30)0025(01)3 0382904490820
  • (10)6118556(17)27 0421(30)0025(01)3 0382904490820
  • (10)6125526(17)27 0501(30)0025(01)3 0382904490820
  • (10)6128740(17)27 0503(30)0025(01)3 0382904490820
  • (10)6132650(17)27 0508(30)0025(01)3 0382904490820
  • (10)6132735(17)27 0510(30)0025(01)3 0382904490820
  • (10)6148198(17)27 0518(30)0025(01)3 0382904490820
  • (10)6148397(17)27 0524(30)0025(01)3 0382904490820

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Becton Dickinson & Co.

See all →