FDA recall, , High risk
Bard Access Systems BD Needle Kit for Powered Driver
BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially delaying therapy and causing serious injury or death.
Summary by Recall Canary from the FDA notice
What happened
Bard Access Systems, Inc., of Salt Lake City, Utah, recalled BD Needle Kit for Powered Driver 15mm x 15Ga, 25mm x 15Ga, 35mm x 15Ga, 45mm x 15Ga, and 55mm x 15Ga, after reports that users experienced difficulty or inability to remove the obturator due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement and delayed therapy. The recall began July 30, 2026, and was added to the FDA's Enforcement Report on August 14, 2026.
The products were distributed in U.S. states including Alabama, Arkansas, Arizona, California, and Florida, and outside the U.S. in CA and SG. The recall is to the user level.
What to do
If a code on your device is listed below:
- Customers and distributors should immediately discontinue use of these lots and destroy all affected needle sets in accordance with their facility’s process.
- 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: productcomplaints@
bd.com. - 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.
Is your kit affected?
Compare every listed detail under your product with its label.
A UDI-DI is the device identifier printed with the barcode on the device label.
Needle Kit for Powered Driver 15mm x 15Ga
- Catalog no.
- D015151NK
- UDI-DI
- 00801741163586
- Lot code
- Appendix 1 in customer letter*
- Best-by or expiration date
- See Appendix 1 in customer letter*
Needle Kit for Powered Driver 25mm x 15Ga
- Catalog no.
- D015251NK
- UDI-DI
- 00801741163678
- Lot code
- Appendix 1 in customer letter*
- Best-by or expiration date
- See Appendix 1 in customer letter*
Needle Kit for Powered Driver 35mm x 15Ga
- Catalog no.
- D015351NK
- UDI-DI
- 00801741163593
- Lot code
- Appendix 1 in customer letter*
- Best-by or expiration date
- See Appendix 1 in customer letter*
Needle Kit for Powered Driver 45mm x 15Ga
- Catalog no.
- D015451NK
- UDI-DI
- 00801741163609
- Lot code
- Appendix 1 in customer letter*
- Best-by or expiration date
- See Appendix 1 in customer letter*
Needle Kit for Powered Driver 55mm x 15Ga
- Catalog no.
- D015551NK
- UDI-DI
- 00801741163616
- Lot code
- Appendix 1 in customer letter*
- Best-by or expiration date
- See Appendix 1 in customer letter*
Recall details
- Company began the recall
- Sold in
US: Massachusetts, Florida, Iowa, South Carolina, Illinois, New York, Utah, New Jersey, Idaho, Indiana, Pennsylvania, California, Texas, Ohio, Missouri, Virginia, Maryland, North Carolina, Alabama, Minnesota, Colorado, Kentucky, Louisiana, Nevada, Oklahoma, Mississippi, Arizona, Michigan, Georgia, Arkansas, Kansas, Tennessee. OUS: California, SG
- Company
- Bard Access Systems, Inc.Salt Lake City, Utah
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99484
- Recall number
- Z-2872-2026
All recalls from Bard Access Systems, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall · Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Summary updated
