Injection Needle

Active United States Open recall

510(k) K834403

Regulatory status

as of 29 Oct 2026

Recall ongoing. 12 ongoing FDA recalls name this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK834403	Date4 Feb 1984Cleared	StatusActive

1 jurisdiction

United States — FDA 510(k) Active

12 recalls · 12 ongoing · FDA

9 recalls, same reason
- Ongoing Z-0472-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0469-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0471-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0468-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0474-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0473-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0476-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0470-2025 FDA Class II initiated 4 Oct 2024
- Ongoing Z-0475-2025 FDA Class II initiated 4 Oct 2024
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
3 recalls, same reason
- Ongoing Z-0021-2023 FDA Class II initiated 29 Jul 2022
- Ongoing Z-0032-2023 FDA Class II initiated 29 Jul 2022 on shared 510(k) K834403
- Ongoing Z-0020-2023 FDA Class II initiated 29 Jul 2022
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k)