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WellFine®

MEDEXEL CO.,LTD. · Model WellFine®Insulin Pen Needles 34Gx4mm 100pcs · UDI-DI 08809445832007

FMI Prescription

510(k) clearances

39,876

Adverse events (68 deaths)

311

Recalls

449

Facilities

Description

Well 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). Well Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Well 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
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 entire needle assembly

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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.