Data Foundry

Medical device recalls 2019

Kit BD Max MRSA — Class II medical device recall Z-2328-2019

Terminated recall by Becton Dickinson & Co., reported 2019-08-28, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Recall numberZ-2328-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Co., Sparks, MD, United States
Recall initiated2019-07-17
Classified2019-08-22
Reported by FDA2019-08-28
Terminated2020-05-13
DistributedAL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV
Countries outside the USAU, BE, BR, CA, CL, CN, HK, JP, KR, MX, SG, TW
Quantity176 units
UPC / GTIN / UDI-DI00382904429539
Lot numbers9071522
Model numbers442953
Expiration dates2019-12-19

Product

Kit BD Max MRSA; Catalog # 442953

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2328-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.