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0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co.,…

Lack of Assurance of Sterility

Class II Medicine & devices FDA April 22, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Huons Co., Ltd. — Jecheon, N/A
Severity
Class II — moderate
Reported
April 22, 2026
Quantity
7,120,750 ampules
Recall number
D-0531-2026
Status
Ongoing
Source
FDA

Where it went

USA Nationwide.

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