Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 3, 2019
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusate…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Company recalled SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 - a critical-severity action.
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696 was recalled by Becton Dickinson & Company in July 3, 2019. Reason: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-…. Check the official notice for the remedy. Verify recall #Z-1210-2019 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this critical-severity FDA Devices recall-Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-….
- Critical
- severity level
- Class I
- classification
- July 3, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1210-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1210-2019) was formally reported on July 3, 2019, with the manufacturer initiating the action on February 28, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records list the affected scope as 2900 Sets.
The documented reason for this recall is: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of AR, NH, NC. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2900 Sets
Related Recalls
6
3 from same agency
Product description
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Reason for recall
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1210-2019 |
| Date reported | July 3, 2019 |
| Date initiated | February 28, 2019 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | 2900 Sets |
| Distribution | US Nationwide Distribution in the states of AR, NH, NC |
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-1210-2019) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696. Recalled by Becton Dickinson & Company. Units affected: 2900 Sets.
Why was this product recalled? ▼
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2019. Severity: Critical. Recall number: Z-1210-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of AR, NH, NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1210-2019) 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 July 3, 2019. 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.