Bard Access Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1397-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Intraosseous needle and driver. 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)

Product Classification:

Class I

Date Initiated: June 20, 2022

Date Posted: August 3, 2022

Recall Number: Z-1397-2022

Event ID: 90315

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 40,734

Code Information:

Catalog/UDI/Lot: D015151NK/801741163586/, 121460, 122145, 123307, 125298, 125534, 125662, 126095, 126467, 126677, 127040, 127711, 128002, 128208, 128778; D015151MK/801741163623/122359; D015251NK/801741163678/121496, 122096, 123306, 125299, 125533, 125535, 126075, 126149, 126178, 126569, 126686, 127118, 127170, 127417, 127756, 128001; 128482, 128829; D015251MK/801741163630/122193; D015351NK/801741163593/125721, 126901, 126939, 128385; D015351MK/801741163647/125842; D015451NK/801741163609/121593, 122169, 123305, 125016, 125517, 125770, 125977, 126299, 126300, 126340, 126575, 127092, 127119, 127300, 127516, 127808, 128120, 128487, 128725; D015451MK/801741163654/122375, 123433; D015551NK/801741163616/125841, 126951, 127003, 127496, 128724; D015551MK/801741163661/125843, 126834; D001001/00801741163579/All Lots

Distribution Pattern:

Distribution US nationwide and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated