BD Needle Kit for Powered Driver Recall Due to Removal Difficulty
Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Bard Access Systems, Inc. is recalling specific lots of BD Needle Kits for Powered Drivers. The affected products include needle kits with lengths of 15mm, 25mm, 35mm, 45mm, and 55mm, all with a 15-gauge needle. The recall covers 80,200 units distributed to 32 states in the United States and two countries outside the US.
The recall is due to out-of-tolerance dimensions and unclear instructions for use, which may cause the obturator to lock to the needle hub. This issue may result in difficulty or inability to remove the obturator after the needle is placed. If the obturator cannot be removed, a new needle may need to be placed, which could delay necessary medical therapy.
These needle sets are used in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain. Users should check their inventory for the specific reference numbers and lot codes listed in the official recall notice. If the product is in use, healthcare providers should follow their institution's protocols for managing the device and patient care.
The recalled product
- Product
- 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…
- Manufacturer
- Bard Access Systems, Inc.
- Affected units
- 80,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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)
Distribution
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