Highest risk U.S. Food and Drug Administration

BD Intraosseous Vascular Access System Needle Sets recall: Due to Reports of Difficulty Removing the Obturator

Recall published 3 months ago

Due to Reports of Difficulty Removing the Obturator

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Delays to therapy initiation may result in serious injury or death.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
July 30, 2026
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
BD
Product type
Medical devices
UPC codes
00801741163586

Products covered by this recall

Intraosseous Vascular Access System Needle Sets

What the company announced

FRANKLIN LAKES, N.J. (July 31, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling specific lots of BD® Intraosseous Vascular Access System Needle Sets to the user level. These products are being recalled following reports that some users experienced difficulty removing the obturator (stylet) after placement of the needle set. Based on complaint reports, bench testing completed by BD and clinical observations, this may occur if the drill is not pulled straight back during insertion or if the obturator is incorrectly rotated during removal.

The affected lots were manufactured with out of tolerance dimensions and distributed between September 30, 2024, and June 12, 2026. This recall does not affect the BD® Intraosseous Powered Driver.

Risk Statement : If the obturator cannot be removed, the clinician may need to obtain a new IO needle or alternative vascular access device, such as a Peripheral IV catheter, potentially delaying therapy initiation. Patients at greatest risk are critically ill individuals requiring urgent vascular access, including out-of-hospital cardiac arrest and severe trauma patients. Delays to therapy initiation may result in serious injury or death. Through June 2026, BD has received 75 complaints and reported 45serious injury reports. BD has also reported 4 deaths in which the inability to remove the stylet occurred during resuscitation efforts for out-of-hospital cardiac arrests.

  • Product Name: Needle Kit for Powered Driver 15mm x 15Ga · Catalog No.: D015151NK · Lot No.: See Appendix 1 in customer letter* · UDI-DI: 00801741163586 · Expiration Date: See Appendix 1 in customer letter* · Product Package Size: 6 kits per case
  • Product Name: Needle Kit for Powered Driver 25mm x 15Ga · Catalog No.: D015251NK · Lot No.: 00801741163678
  • Product Name: Needle Kit for Powered Driver 35mm x 15Ga · Catalog No.: D015351NK · Lot No.: 00801741163593
  • Product Name: Needle Kit for Powered Driver 45mm x 15Ga · Catalog No.: D015451NK · Lot No.: 00801741163609
  • Product Name: Needle Kit for Powered Driver 55mm x 15Ga · Catalog No.: D015551NK · Lot No.: 00801741163616

*Additional information can be found in the customer letter, available here .

BD is notifying its customers and distributors who may have received these lots of product directly. Customers and distributors should immediately discontinue use of these lots and destroy all affected needle sets in accordance with their facility’s process.

BD will issue replacement for destroyed product of the affected lot numbers to customers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form.

BD has identified the root cause of this issue and implemented corrective and preventative action, including product and labeling improvements, to enhance device robustness and reduce the likelihood of recurrence. Product distributed outside of the affected production window is not impacted.

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s North American Regional Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 8 a.m. and 5 p.m. CT or by emailing: [email protected] .

FDA MedWatch Reporting

Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program either online, phone or by regular mail.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Call 1-800-FDA-1088 (1-800-332-1088)

Regular Mail : MedWatch, HF-2, FDA, 5600 Fisher’s Lane, Rockville, MD 20852-9787

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

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About BD

BD is one of the world’s largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ , X @BDandCo or Instagram @becton_dickinson .

Contacts:

Media

Matt Marcus

VP, Public Relations

[email protected]

Investors

Shawn Bevec

SVP, Investor Relations

[email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00801741163586

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 00801741163678
  • 00801741163593
  • 00801741163609
  • 00801741163616

Model or item number

On the rating label, the box or the instruction sheet.

  • D015151NK
  • D015251NK
  • D015351NK
  • D015451NK
  • D015551NK

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

BD — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Remedy named in the notice: Customers and distributors should immediately discontinue use of these lots and destroy all affected needle sets in accordance with their facility’s process.

Company contact: (Becton, Dickinson and Company) — Consumers: BD’s North American Regional Complaint Center, 1-844-823-5433, [email protected] — Media: Matt Marcus VP, Public Relations, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BD medical devices recalled?

Due to Reports of Difficulty Removing the Obturator Delays to therapy initiation may result in serious injury or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00801741163586; lot code 00801741163678, 00801741163593, 00801741163609; model number D015151NK, D015251NK, D015351NK. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Customers and distributors should immediately discontinue use of these lots and destroy all affected needle sets in accordance with their facility’s process.

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