Intraosseous needle and driver — Class I medical device recall Z-1397-2022
Ongoing recall by Bard Access Systems, Inc., reported 2022-08-03, distributed nationwide. BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous ne
| Recall number | Z-1397-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2022-06-20 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 40,734 |
| UPC / GTIN / UDI-DI | 00801741163579, 00801741163586, 00801741163593, 00801741163609, 00801741163616, 00801741163623, 00801741163630, 00801741163647, 00801741163654, 00801741163661, 00801741163678 |
| Lot numbers | 121460, 122096, 122145, 122169, 123305, 123306, 123307, 123433, 125016, 125298, 125299, 125517, 125533, 125534, 125535, 125662, 125770, 125977, 126075, 126095, 126149, 126178, 126299, 126300, 126340, 126467, 126569, 126575, 126677, 126686, 126834, 126901, 126939, 126951, 127003, 127040, 127092, 127118, 127119, 127170 and 29 more |
Product
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1397-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.