Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 30, 2015
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore,
Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Company recalled BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vac… - a moderate-severity action.
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vac… was recalled by Becton Dickinson & Company in December 30, 2015. Reason: Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stoppe…. Check the official notice for the remedy. Verify recall #Z-0456-2016 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this moderate-severity FDA Devices recall-Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stoppe….
- Moderate
- severity level
- 4.8M units
- affected scope
- Class II
- classification
- December 30, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0456-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0456-2016) was formally reported on December 30, 2015, with the manufacturer initiating the action on November 17, 2015. It is classified under Moderate severity (Class II), 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 4,835,000 units, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood spl… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.. 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
4,835,000 units
Related Recalls
6
3 from same agency
Product description
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
Reason for recall
Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0456-2016 |
| Date reported | December 30, 2015 |
| Date initiated | November 17, 2015 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | 4,835,000 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea. |
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-0456-2016) 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 Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.. Recalled by Becton Dickinson & Company. Units affected: 4,835,000 units.
Why was this product recalled? ▼
Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0456-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0456-2016) 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 30, 2015. 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.