Home › Device types › FMI
Needle, Hypodermic, Single Lumen
FDA product code FMI · Class 2 · General Hospital
0
Registered devices
40,761
Adverse events
311
Recalls
694
510(k) clearances
Devices with this code
True Comfort Insulin Pen Needles 32G 4mm — HOME AIDE DIAGNOSTICS, INC.TKMD — Anhui Tiankang Medical Technology Co., Ltd.CarePoint Precision — ALLISON MEDICAL, INC.Diabetic Outlet - Unifine Pentips Plus — OWEN MUMFORD USA INCORPORATEDdroplet® pen needles — HTL STREFA S ARELI — MYCO MEDICAL SUPPLIES INC.Micsafe — Jiangsu Micsafe Medical Tehcnology Co.,LTD.RELI® — MYCO MEDICAL SUPPLIES INC.Omnican® fine — B. Braun Melsungen AktiengesellschaftRejubeau Extra Fine Cannula 27G x 50mm — Feeltech Co.,Ltd.Verifine — Promisemed Medical Devices Inc.RELI® — MYCO MEDICAL SUPPLIES INC.Clever Choice Comfort EZ — SIMPLE DIAGNOSTICS INCDoctors Choice — Supply Line International Medical, LLCLiteTouch — AMITY HOLDINGS, LLCARROW — TELEFLEX INCORPORATEDSHOPKO Unifine Pentips Plus - 5mmx31G pen needles — ShopkoMonoject — Cardinal Health, Inc.Nipro Syringe — NIPRO MEDICAL CORPORATIONVacuette — Greiner Bio-One GmbHBioCare Safety Needles — BIOTRONIX HEALTHCARE INDUSTRIES, INC.SURGYCO — Surgyco LLCJelco — ICU MEDICAL, INC.EasyTouch — MHC MEDICAL PRODUCTS, 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 |
| 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.