Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 6, 2017
BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly la…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Company recalled BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466… - a moderate-severity action.
BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466… was recalled by Becton Dickinson & Company in December 6, 2017. Reason: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (…. Check the official notice for the remedy. Verify recall #Z-0183-2018 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this moderate-severity FDA Devices recall-Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (….
- Moderate
- severity level
- 7.8M units
- affected scope
- Class II
- classification
- December 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0183-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0183-2018) was formally reported on December 6, 2017, with the manufacturer initiating the action on May 25, 2017. 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 7,839,340 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: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31… Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA. 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 - 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 - 40,422 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
7,839,340 units
Related Recalls
6
0 from same agency
Product description
BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
Reason for recall
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle ¿mL 12.7mm 30G.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0183-2018 |
| Date reported | December 6, 2017 |
| Date initiated | May 25, 2017 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | 7,839,340 units |
| Distribution | Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA |
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-0183-2018) 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 Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin. Recalled by Becton Dickinson & Company. Units affected: 7,839,340 units.
Why was this product recalled? ▼
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle ¿mL 12.7mm 30G.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0183-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0183-2018) 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 6, 2017. 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.