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Sure Comfort

ALLISON MEDICAL, INC. · Model 22-6504 · UDI-DI 00786227650456

FMF

510(k) clearances

53,081

Adverse events (66 deaths)

305

Recalls

546

Facilities

Description

0.3mL 31G 8mm Single use disposable insulin syringe with needle and half unit measure. Includes 100 sterile syringes in convenient 10 pack bags.

Recalls

Date	Firm	Reason
2026-04-28	Mentor Texas LP	A single lot of expired syringes were distributed due to a distribution system control failure.
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-02-27	Cardinal Health 200, LLC	The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages
2026-01-27	Becton Dickinson & Company	During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
2025-05-23	Integra LifeSciences Corp. (NeuroSciences)	Lack of sterility assurance.
2025-05-22	Integra LifeSciences Corp. (NeuroSciences)	Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22	Integra LifeSciences Corp. (NeuroSciences)	Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22	Integra LifeSciences Corp. (NeuroSciences)	Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-12	BD SWITZERLAND SARL	Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the
2025-05-12	BD SWITZERLAND SARL	Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the

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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.