Device recalls

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit f…

Bard Access Systems, Inc. · After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary…

Open, ClassifiedComponent change controlZ-2872-2026
Open FDA's page for this record
Cfres ID
221651
Product res number
Z-2872-2026
Event date initiated
2026-07-30
Event date posted
2026-08-14
Recall status
Open, Classified
Res event number
99484
Product code
FMI
Firm FEI number
3006260740
Recalling firm
Bard Access Systems, Inc.
Address 1
605 N 5600 W
City
Salt Lake City
State
UT
Postal code
84116-3738
Additional info contact
801-522-5000
Root cause description
Component change control
Product quantity
80,200
Distribution pattern
US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA, AR, KS, TN. OUS: CA, SG
Product description

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK

Code info

REF/UDI-DI/Lot(Expiration): D015151NK/00801741163586/BSLC9275(2026-08-03), BSLC9563(2026-08-13), BSLC9567(2026-08-25), BSLC10103(2026-09-27), BSLC10516(2026-11-01), BSLC10526(2026-11-16), BSLC10872(2026-12-09), BSLC11216(2028-07-02), BSLC11456(2028-07-23); D015251NK/00801741163678/BSLC9467(2026-08-10), BSLC9575(2026-09-20), BSLC10105(2026-10-04), BSLC10522(2026-11-07), BSLC10868(2026-12-02), BSLC11212(2028-06-18), BSLC11454(2028-07-17), BSLC11463(2028-08-07), BSLC11884(2028-09-15), BSLC11890(2028-09-18), BSLC12082(2028-10-08), BSLC12115(2028-10-20), BSLC12123(2028-10-22); D015351NK/00801741163593/BSLC11458(2028-07-24); 00801741163678/BSLC9277(2026-08-04), BSLC9485(2026-08-12), BSLC9569(2026-08-26), BSLC10099(2026-09-07), BSLC10514(2026-10-16), BSLC10518(2026-10-21), BSLC10524(2026-11-08), BSLC10870(2026-12-03), BSLC10874(2028-06-12), BSLC11218(2028-07-07); D015451NK/00801741163609/BSLC9279(2026-08-06), BSLC9565(2026-08-17), BSLC9571(2026-09-07), BSLC10101(2026-09-17), BSLC10456(2026-10-14), BSLC10520(2026-10-22), BSLC10866(2026-11-21), BSLC11214(2028-06-23), BSLC11450(2028-07-09), BSLC11460(2028-07-31), BSLC11873(2028-08-13), BSLC11888(2028-09-25), BSLC12007(2028-10-02), BSLC12105(2028-10-15); D015551NK/00801741163616/BSLC9465(2026-08-07), BSLC9573(2026-09-26), BSLC10107(2026-10-02), BSLC10528(2026-11-20), BSLC11452(2028-07-10)

Reason for recall

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

Action

On 7/30/2026, recall notices were mailed/emailed: If rotation and locking occurs, the clinician may need to obtain a new IO needle or other form of vascular access device, such as a Peripheral IV catheter. Alternate vascular access approaches, including additional peripheral IV attempts, or central venous access may continue to be pursued based on clinical judgment/protocols. Affected product should not be used to establish IO access. For patients in whom potentially affected intraosseous needles are currently in use/or have been used and are/were functioning properly, no additional steps need to be taken. 1. Destroy all affected needle set kits, or quarantined until disposal. 2. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 3. Complete and return the attached Customer Response Form via email to bdrc16@bd.com Distributors were also asked to do the following: - A customer letter template is provided to create your own letter to be sent to all customers. - Provide product replacement for all product destroyed by your customer. Questions contact firm at 1-844-823-5433 or productcomplaints@bd.com Firm has acquired new molds with improved dimensional controls. Instructions For Use will be updated with the following to optimize needle / obturator(stylet) / drill handling: Do not pull back on the drill and needle, release the trigger prematurely, or rock/bend the needle during insertion. These actions may result in the needle and drive adapter hubs to rotate and lock together resulting in a bent needle, difficult stylet removal, need for a new device, and/or delay in therapy. Warning: Do not rotate or try to unscrew the drive adapter hub while removing the stylet. These actions may cause the needle and drive adapter hubs to rotate and lock together, resulting in difficult stylet removal, need for a new device, and/or delay in therapy.

K numbers
K191976, K203193
Harmonized identifiers (openFDA)
Device name
Needle, Hypodermic, Single Lumen
Medical specialty description
General Hospital
Regulation number
880.5570
Device class
2
K number
K970383, K960933, K936029, K102584, K220603, K951515, K142765, K813648, K230635, K052843, K881654, K925086, K180545, K052408, K761098, K861318, K233037, K131954, K100124, K170824, K934435, K943794, K021315, K944114, K001853, K024109, K915409, K905664, K160887, K925056, K152877, K904295, K002180, K231723, K062956, K890620, K061032, K000085, K891919, K132583 +654 more
Registration number
3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1836161, 1017768, 3004458481, 3006973666, 3004143450, 3017509841, 2032098, 1319211, 3010872792, 3016884191, 3003916417, 3015727296, 3014479313, 3009853488, 9610847, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 9614279, 3007007790, 2027487, 1000523114 +414 more
FEI number
3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3010862763, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1017768, 3004458481, 3006973666, 1000112877, 3008002452, 3004143450, 3017509841, 1319211, 3001570557, 3010872792, 3016884191, 3003169040, 3004521048, 1000174591, 3015727296, 3014479313, 3009853488, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 3007007790 +414 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.