Becton Dickinson & Co.: Medical Device Recall in 2025 - (Recall #: Z-1004-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BD PCR Cartridges used with MAX System. Model Number: 437519

Product Classification:

Class II

Date Initiated: December 19, 2024

Date Posted: January 29, 2025

Recall Number: Z-1004-2025

Event ID: 95963

Reason for Recall:

Potential for signal drift in specific lots of BD PCR Cartridges.

Status: Ongoing

Product Quantity: 516,435 units

Code Information:

Model Number: 437519. UDI Numbers: (01)30382904375196(17)261205(10)4323345, (01)30382904375196(17)261129(10)4317725, (01)30382904375196(17)261122(10)4309022, (01)30382904375196(17)261115(10)4302135, (01)30382904375196(17)261111(10)4296086, (01)30382904375196(17)261104(10)4289593, (01)30382904375196(17)261029(10)4281532, (01)30382904375196(17)261021(10)4275828, (01)30382904375196(17)261014(10)4268747, (01)30382904375196(17)261007(10)4254714, (01)30382904375196(17)260930(10)4254710, (01)30382904375196(17)260923(10)4247089, (01)30382904375196(17)260913(10)4239079, (01)30382904375196(17)260909(10)4233297, (01)30382904375196(17)260902(10)4225364, (01)30382904375196(17)260826(10)4204545, (01)30382904375196(17)260805(10)4198065, (01)30382904375196(17)260729(10)4191581, (01)30382904375196(17)260722(10)4185634, (01)30382904375196(17)260716(10)4178328, (01)30382904375196(17)260704(10)4164798, (01)30382904375196(17)260701(10)4164796, (01)30382904375196(17)260701(10)4164792, (01)30382904375196(17)260701(10)4164794, (01)30382904375196(17)260701(10)4164789, (01)30382904375196(17)260624(10)4149773, (01)30382904375196(17)260617(10)4149768, (01)30382904375196(17)260610(10)4143963, (01)30382904375196(17)260605(10)4142324, (01)30382904375196(17)260604(10)4136790, (01)30382904375196(17)260528(10)4130663,(01)30382904375196(17)260527(10)4130589, (01)30382904375196(17)260520(10)4121669, (01)30382904375196(17)260517(10)4117376, (01)30382904375196(17)260513(10)4114952, (01)30382904375196(17)260506(10)4107497, (01)30382904375196(17)260429(10)4100041, (01)30382904375196(17)260422(10)4093507.

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.

Voluntary or Mandated:

Voluntary: Firm initiated