Home › Device types › FMI
Needle, Hypodermic, Single Lumen
FDA product code FMI · Class 2 · General Hospital
6,319
Registered devices
39,692
Adverse events
309
Recalls
692
510(k) clearances
Devices with this code
CAINA — Jiangsu Caina Medical Co.,LtdRELI® — MYCO MEDICAL SUPPLIES INC.Comfort EZ — S.D.I. USA, INC.RELI® — MYCO MEDICAL SUPPLIES INC.LiteTouch — AMITY HOLDINGS, LLCMagellan — Cardinal Health, Inc.RELI® — MYCO MEDICAL SUPPLIES INC.Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLCBD Intraosseous Vascular Access System — Bard Access Systems, Inc.RELI® — MYCO MEDICAL SUPPLIES INC.UltiCare — ULTIMED, INC.Doctors Choice — Supply Line International Medical, LLCMedline — MEDLINE INDUSTRIES, INC.RELI® — MYCO MEDICAL SUPPLIES INC.Medegen Medical products — MEDEGEN MEDICAL PRODUCTS, LLCRELI® — MYCO MEDICAL SUPPLIES INC.STERICAN™ — B. BRAUN MEDICAL INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Safety Blood Collection Needle (Without Needle Holder) — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDAQUILAVIE — Ahc Americas LLCUltiCare — ULTIMED, INC.SOL-Guard Safety Needle — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDINSULIN PEN NEEDLE — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDSURGYCO — Surgyco LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | 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 |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2024-11-19 | Greiner Bio-One GmbH | The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device. |
| 2024-06-18 | Embecta Corp. | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrit |
| 2024-02-05 | Retractable Technologies, Inc. | The needle cannula of a retractable needle may detach from the needle holder in the patient. |
| 2023-08-22 | Apellis Pharmaceuticals, Inc. | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established betwee |
| 2022-06-20 | Bard Access Systems, Inc. | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the ent |
| 2021-08-24 | Zhejiang Kindly Medical Devices Co., Ltd. | Potential for difficulty in safety mechanism activation. |
| 2021-08-24 | Zhejiang Kindly Medical Devices Co., Ltd. | Potential for difficulty in safety mechanism activation. |
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