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ALLISON MEDICAL, INC.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
CarePoint Precision	04-0001	FDA UDI	Class II	Active
Sure Comfort	24-1308	FDA UDI	Class II	Active
CarePoint Precision	202-2115	FDA UDI	Class II	Active
CarePoint Precision	202-1801	FDA UDI	Class II	Active
CarePoint Precision	04-0020	FDA UDI	Class II	Active
CarePoint Precision	505-3105	FDA UDI	Class II	Active
Sure Comfort	22-6210	FDA UDI	Class II	Active
Sure Comfort	22-6504	FDA UDI	Class II	Active
Sure Comfort	22-8005	FDA UDI	Class II	Active
CarePoint Precision	202-2315	FDA UDI	Class II	Active
CarePoint Precision	04-0030	FDA UDI	Class II	Active
Good Neighbor Pharmacy	10293579	FDA UDI	Class II	Active
CarePoint Precision	202-2558	FDA UDI	Class II	Active
CarePoint Precision	505-3135	FDA UDI	Class II	Active
CarePoint Precision	505-3101	FDA UDI	Class II	Active
Allison Medical Syringe	K932001	FDA 510(k)	Class II	Active
Allison Medical Insulin Syringe (amis)	K984017	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 3, 2020	Z-0478-2023	—	completed	Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Jan 19, 2018	Z-0266-2023	—	completed	Insulin syringe retail packages incorrectly labeled as "Short Needle".