Key facts
| Recalling firm | Huons Co., Ltd. |
|---|---|
| Manufacturer | Spectra Medical Deviecs, LLC |
| Brand name | SODIUM CHLORIDE |
| Product description | 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., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. |
| Classification | Class II |
| Recall number | D-0531-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Lack of Assurance of Sterility |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Huons Co., Ltd. and the affected product is described in FDA's record as: 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., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.. FDA's stated reason for the recall is: Lack of Assurance of Sterility. The recall is tracked under FDA recall number D-0531-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. -- and the recall number D-0531-2026. If it matches, stop using or distributing it and contact Huons Co., Ltd. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
Huons Co., Ltd.’s FDA history
Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd.: 1 warning letter, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What was recalled and why?
- Huons Co., Ltd. recalled 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., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.. FDA's record states the reason for recall as: Lack of Assurance of Sterility. The recall is logged under FDA recall number D-0531-2026 with a Class II classification.
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.) and recall number D-0531-2026, then follow Huons Co., Ltd.'s recall instructions.
- Has Huons Co., Ltd. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd., including 4 recalls and 1 warning letter.
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Related enforcement actions
Full FDA history for Huons Co., Ltd.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Recall Record: Class II Recall: SODIUM CHLORIDE by Huons Co., Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0531-2026
"Recall Record: Class II Recall: SODIUM CHLORIDE by Huons Co., Ltd.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-huons-co-ltd-d-0531-2026.
Argus HQ Research. "Recall Record: Class II Recall: SODIUM CHLORIDE by Huons Co., Ltd.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0531-2026.
@misc{argushq_argushq_ai_recall_fda_recall_huons_co_ltd_d_0531_2026_2026,
title = {Recall Record: Class II Recall: SODIUM CHLORIDE by Huons Co., Ltd.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-huons-co-ltd-d-0531-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗