Home › Device types › FMI
Needle, Hypodermic, Single Lumen
FDA product code FMI · Class 2 · General Hospital
6,413
Registered devices
40,761
Adverse events
311
Recalls
694
510(k) clearances
Devices with this code
Sterile Single-use Syringe with Needle — Jiangxi Hongda Medical Equipment Group Ltd.STERiJECT TM — TSK LABORATORY, JAPANOmnifix™ — B. BRAUN MEDICAL INC.Clever Choice Comfort EZ — SIMPLE DIAGNOSTICS INCMonoject — Cardinal Health 200, LLCMonoject — Cardinal Health 200, LLCEXEL Multi Sample Luer Adapter — Exel InternationalVacuette — Greiner Bio-One GmbHRELI — MYCO MEDICAL SUPPLIES INC.GLUCO-CARE PLUS Pen Needles — MediVena, LLCMonoject — Cardinal Health 200, LLCMonoject — Cardinal Health 200, LLCHSW HENKE-JECT® — Henke-Sass, Wolf GmbHCarePoint Precision — ALLISON MEDICAL, INC.CarePoint Precision — ALLISON MEDICAL, INC.CareTouch — WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.Ceros — Rhino Medical Supply IncPure Comfort Insulin Pen Needles 32G 5mm 50cnt — HOME AIDE DIAGNOSTICS, INC.LEADER, pen needles — HTL STREFA S ANIPRO SafeTouch™ Safety Scalp Vein Set — NIPRO MEDICAL CORPORATIONRELI — MYCO MEDICAL SUPPLIES INC.Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.Endure — ENDURE INDUSTRIEShypodermic needles — Berpu Medical Technology Co.,Ltd
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 |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 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 |
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