Use caution Medical device recall · FDA · Published June 20, 2022

Bard Access Systems Intraosseous Needle Kits Recall: Risk of Needle Assembly Loss

Bard Access Systems recalls Intraosseous needle kits with potential for needle assembly loss during use. Affected models include D015151NK, D015151MK, and others. Stop using immediately to prevent injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1397-2022Medical device Bard Access Systems ›

Use caution until it’s fixed

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

Take action

Contact the company

Recalling firmBard Access Systems, Inc.605 N 5600 W · Salt Lake City, UT 84116-3738

✎ GovInfoNow plain-language explainer

Bard Access Systems is recalling several intraosseous needle kits due to risks of needle assembly loss or failure during use. This could lead to loss of intraosseous access or injury if the stylet safety mechanism doesn't engage properly. Read more at govinfonow.com/recall/60477-bard-access-systems-intraosseous-needle-kits-recall-risk-of-needle.

Source Summary by GovInfoNow · govinfonow.com/recall/60477-bard-access-systems-intraosseous-needle-kits-recall-risk-of-needle · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1397-2022

Cite this page

“Bard Access Systems Intraosseous Needle Kits Recall: Risk of Needle Assembly Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60477-bard-access-systems-intraosseous-needle-kits-recall-risk-of-needle. Based on FDA recall #Z-1397-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1397-2022%22&limit=1).

The FDA announced on June 20, 2022, that Bard Access Systems, Inc. is recalling intraosseous needle and driver kits due to potential stylet removal issues and driver malfunctions. The agency classified the recall as Class I.

How to tell if you have it

Brand: Bard Access Systems
Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)
Lot codes: 801741163586/121460, 122145, 123307, 125298, 125534, 125662, 126095, 126467, 126677, 127040, 127711, 128002, 128208, 128778; 801741163623/122359; 801741163678/121496, 122096, 123306, 125299, 125533, 125535, 126075, 126149, 126178, 126569, 126686, 127118, 127170, 127417, 127756, 128001; 128482, 128829; 801741163630/122193; 801741163593/125721, 126901, 126939, 128385; 801741163647/125842; 801741163609/121593, 122169, 123305, 125016, 125517, 125770, 125977, 126299, 126300, 126340, 126575, 127092, 127119, 127300, 127516, 127808, 128120, 128487, 128725; 801741163654/122375, 123433; 801741163616/125841, 126951, 127003, 127496, 128724; 801741163661/125843, 126834; 00801741163579/All Lots
Units affected: 40,734

The hazard

According to the FDA, BD Intraosseous Needle Kits may exhibit increased force required to remove the stylet, which could cause loss of intraosseous access. The stylet safety mechanism may also fail to engage during removal, and metal discs in the powered driver may stick, rendering the device unusable.

Context

GovInfoNow's records show Bard Access Systems, Inc. has 8 other recalls on record since December 28, 2017. Other recent recalls of similar products include Bard Power-Trialysis Dialysis Catheters (August 10, 2026), Bard Needle Kits for Powered Driver (July 30, 2026), and Bard PowerPICC SOLO HF Catheter Recall (May 21, 2026). Other recent recalls of similar products include Medline medical kits (February 27, 2026) and Merit Medical Custom Procedure Kit Recall (December 4, 2025).

How to tell if you have this one

Check for model numbers starting with D015151NK, D015151MK, D015251NK, D015251MK, D015351NK, D015351MK, D015451NK, D015451MK, D015551NK, D015551MK, or D001001. Affected kits have specific lot numbers listed in the recall notice.

Brand
Bard Access Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the recalled needle kits to prevent potential loss of needle assembly or injury.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Distribution US nationwide and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Jun 20, 2022Firm started the recall
Jul 22, 2022FDA classified it Class I
Aug 3, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/60477-bard-access-systems-intraosseous-needle-kits-recall-risk-of-needle">Bard Access Systems Intraosseous Needle Kits Recall: Risk of Needle Assembly Loss (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1397-2022 (June 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1397-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.