RegWardenFDA facility compliance records
Recall

Class II — Becton Dickinson & Co.

Recalling firmBecton Dickinson and Company
Registered facilityView this company's 36 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonBD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
ProductBD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath® Preservative Fluid is designed for use with the PrepStain® System. SurePath® Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.
Quantity16,682.396
DistributionWorldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Pan…
Initiated2016-02-12
Classified2016-12-21
Terminated2016-12-27
Recall numberZ-0877-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Becton Dickinson & Co. (Z-0877-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75886/

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