CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

BD Phoenix Panel Nmic recalled by Becton Dickinson

Becton Dickinson is recalling BD Phoenix Panel Nmic-312, distributed nationwide in the US. The recall was initiated on 13 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 449082. UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (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, (10)6153088(17)27 0525(30)0025(01)3 0382904490820, (10)6153231(17)27 0526(30)0025(01)3 0382904490820, (10)6160397(17)27 0602(30)0025(01)3 0382904490820, (10)6160450(17)27 0605(30)0025(01)3 0382904490820, (10)6166259(17)27 0604(30)0025(01)3 0382904490820, (10)6166265(17)27 0606(30)0025(01)3 0382904490820, (10)6181978(17)27 0622(30)0025(01)3 0382904490820, (10)6181006(17)27 0623(30)0025(01)3 0382904490820, (10)6181015(17)27 0623(30)0025(01)3 0382904490820, (10)6181164(17)27 0626(30)0025(01)3 0382904490820, (10)6181151(17)27 0626(30)0025(01)3 0382904490820, (10)6181991(17)27 0622(30)0025(01)3 0382904490820, (10)6188614(17)27 0703(30)0025(01)3 0382904490820, (10)6188641(17)27 0703(30)0025(01)3 0382904490820, (10)6188683(17)27 0705(30)0025(01)3 0382904490820, (10)6188905(17)27 0710(30)0025(01)3 0382904490820, (10)6188922(17)27 0711(30)0025(01)3 0382904490820, (10)6195847(17)27 0713(30)0025(01)3 0382904490820, (10)6195877(17)27 0714(30)0025(01)3 0382904490820. Lot Numbers: 5324466, 5349874, 6008828, 5350977, 6028392, 6034513, 6042998, 6042021, 6056431, 6069033, 6083447, 6098295, 6104811, 6104042, 6118556, 6125526, 6128740, 6132650, 6132735, 6148198, 6148397, 6153088, 6153231, 6160397, 6160450, 6166259, 6166265, 6181978, 6181006, 6181015, 6181164, 6181151, 6181991, 6188614, 6188641, 6188683, 6188905, 6188922, 6195847, 6195877.
Quantity recalled553,625 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0139-2027
FDA event ID
99725
Recalling firm
Becton Dickinson, Sparks, MD
Classification
Class II
Status
Ongoing
Recall initiated
13 Aug 2026
FDA classified
9 Oct 2026
Reported
21 Oct 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Device Malfunction

Timeline

13 Aug 2026Recall initiated by company
9 Oct 2026Classified by FDA+57 days
21 Oct 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Catalog Number: 449082. UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (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, (10)6153088(17)27 0525(30)0025(01)3 0382904490820, (10)6153231(17)27 0526(30)0025(01)3 0382904490820, (10)6160397(17)27 0602(30)0025(01)3 0382904490820, (10)6160450(17)27 0605(30)0025(01)3 0382904490820, (10)6166259(17)27 0604(30)0025(01)3 0382904490820, (10)6166265(17)27 0606(30)0025(01)3 0382904490820, (10)6181978(17)27 0622(30)0025(01)3 0382904490820, (10)6181006(17)27 0623(30)0025(01)3 0382904490820, (10)6181015(17)27 0623(30)0025(01)3 0382904490820, (10)6181164(17)27 0626(30)0025(01)3 0382904490820, (10)6181151(17)27 0626(30)0025(01)3 0382904490820, (10)6181991(17)27 0622(30)0025(01)3 0382904490820, (10)6188614(17)27 0703(30)0025(01)3 0382904490820, (10)6188641(17)27 0703(30)0025(01)3 0382904490820, (10)6188683(17)27 0705(30)0025(01)3 0382904490820, (10)6188905(17)27 0710(30)0025(01)3 0382904490820, (10)6188922(17)27 0711(30)0025(01)3 0382904490820, (10)6195847(17)27 0713(30)0025(01)3 0382904490820, (10)6195877(17)27 0714(30)0025(01)3 0382904490820. Lot Numbers: 5324466, 5349874, 6008828, 5350977, 6028392, 6034513, 6042998, 6042021, 6056431, 6069033, 6083447, 6098295, 6104811, 6104042, 6118556, 6125526, 6128740, 6132650, 6132735, 6148198, 6148397, 6153088, 6153231, 6160397, 6160450, 6166259, 6166265, 6181978, 6181006, 6181015, 6181164, 6181151, 6181991, 6188614, 6188641, 6188683, 6188905, 6188922, 6195847, 6195877.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99725
ReportedClassRecallCompanyReasonWhere
CLASS IIBD Phoenix Panel Nmic recalled by Becton DickinsonBecton DickinsonDevice MalfunctionNationwide

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