Home › MEDEXEL CO.,LTD. › TopFine®

TopFine®

MEDEXEL CO.,LTD. · Model TopFine®Insulin Pen Needles 30Gx8mm 100pcs · UDI-DI 08809445831789

FMI Prescription

510(k) clearances

39,692

Adverse events (67 deaths)

309

Recalls

448

Facilities

Description

Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.

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 cases, users may exp
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 integrity of the device cann
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 between the structural var
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 entire needle assembly
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.

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 key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.