Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 28, 2016
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.
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 preser…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Co. recalled BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 4910… - a moderate-severity action.
BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 4910… was recalled by Becton Dickinson & Co. in December 28, 2016. Reason: BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may…. Check the official notice for the remedy. Verify recall #Z-0877-2017 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may….
- Moderate
- severity level
- 17K units
- affected scope
- Class II
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0877-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0877-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on February 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 16,682.396.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide 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, N…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
16,682.396
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0877-2017 |
| Date reported | December 28, 2016 |
| Date initiated | February 12, 2016 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 16,682.396 |
| Distribution | Worldwide 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, N… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0877-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton Dickinson & Co.. Units affected: 16,682.396.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0877-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide 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, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0877-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.