BD SurePathTM Preservative Collection Vials — Class II medical device recall Z-0877-2017
Terminated recall by Becton Dickinson & Co., reported 2016-12-28, distributed nationwide. BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may
| Recall number | Z-0877-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2016-02-12 |
| Classified | 2016-12-21 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2016-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CN, HK, IN, KR, MX, NZ, PA, SG, TW |
| Quantity | 16,682 |
| Reason classes | packaging |
| Model numbers | 490505, 490527, 491095, 491096, 491097 |
Product
BD 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.
Reason for recall
BD 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.
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-0877-2017. 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.