Z-0139-2027 Class II Ongoing
FDA device recall Z-0139-2027 was initiated by Becton Dickinson & Co. on Aug 13, 2026 and is designated Class II. Reason for recall: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. The recall status is ongoing. Affected quantity: 553,625 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Aug 13, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 553,625 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0139-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026