- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- Affected products (lot / model / serial)
- Catalog Number: 449292. UDI Numbers: (10)5301934(17)26 1102(30)0025(01)3 0382904492923, (10)5301046(17)26 1107(30)0025(01)3 0382904492923, (10)5301019(17)26 1105(30)0025(01)3 0382904492923, (10)5301058(17)26 1108(30)0025(01)3 0382904492923, (10)5301088(17)26 1109(30)0025(01)3 0382904492923, (10)5324448(17)26 1111(30)0025(01)3 0382904492923, (10)5325592(17)26 1122(30)0025(01)3 0382904492923, (10)5336528(17)26 1125(30)0025(01)3 0382904492923, (10)5336554(17)26 1130(30)0025(01)3 0382904492923, (10)5336667(17)26 1203(30)0025(01)3 0382904492923, (10)5336716(17)26 1206(30)0025(01)3 0382904492923, (10)5343520(17)26 1209(30)0025(01)3 0382904492923, (10)5343522(17)26 1221(30)0025(01)3 0382904492923, (10)5350942(17)26 1226(30)0025(01)3 0382904492923, (10)5350876(17)26 1223(30)0025(01)3 0382904492923, (10)5350972(17)26 1228(30)0025(01)3 0382904492923, (10)6006439(17)26 1231(30)0025(01)3 0382904492923, (10)6006497(17)27 0104(30)0025(01)3 0382904492923, (10)6006475(17)27 0103(30)0025(01)3 0382904492923, (10)6013345(17)27 0111(30)0025(01)3 0382904492923, (10)6013300(17)27 0109(30)0025(01)3 0382904492923, (10)6013963(17)27 0118(30)0025(01)3 0382904492923, (10)6013924(17)27 0117(30)0025(01)3 0382904492923, (10)6034519(17)27 0131(30)0025(01)3 0382904492923, (10)6042012(17)27 0203(30)0025(01)3 0382904492923, (10)6042040(17)27 0204(30)0025(01)3 0382904492923, (10)6042153(17)27 0208(30)0025(01)3 0382904492923, (10)6069030(17)27 0309(30)0025(01)3 0382904492923, (10)6082661(17)27 0313(30)0025(01)3 0382904492923, (10)6098326(17)27 0331(30)0025(01)3 0382904492923, (10)6098427(17)27 0405(30)0025(01)3 0382904492923, (10)6104765(17)27 0411(30)0025(01)3 0382904492923, (10)6125411(17)27 0427(30)0025(01)3 0382904492923, (10)6128662(17)27 0430(30)0025(01)3 0382904492923, (10)6138197(17)27 0505(30)0025(01)3 0382904492923, (10)6148207(17)27 0519(30)0025(01)3 0382904492923, (10)6148231(17)27 0520(30)0025(01)3 0382904492923. Lot Numbers: 5301934, 5301046, 5301019, 5301058, 5301088, 5324448, 5325592, 5336528, 5336554, 5336667, 5336716, 5343520, 5343522, 5350942, 5350876, 5350972, 6006439, 6006497, 6006475, 6013345, 6013300, 6013963, 6013924, 6034519, 6042012, 6042040, 6042153, 6069030, 6082661, 6098326, 6098427, 6104765, 6125411, 6128662, 6138197, 6148207, 6148231.
- Units affected
- 669,200 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Sparks, MD, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0140-2027
- Recall initiated
- August 13, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99725
- Last updated on HTM Vibe
- October 27, 2026
