Z-1627-2018Class II

Nanosil Spray Gel, "IMMUNE SYSTEM SUPPORTENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL...

Name: Z-1627-2018 Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL...
Creator: Conseal International, Inc.
Published: 2018-04-25
License: https://open.fda.gov/license/

Conseal International, Inc. / initiated 2018-04-25 / Terminated / root cause: manufacturing process

FDA source

Conseal International, Inc. began a recall of Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray... on 2018-04-25. FDA classified it as Class II and gives the reason as "A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1627-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-25
Posted: 2018-05-03
Terminated: 2019-04-02
Recalling firm: Conseal International, Inc.
Product: Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
Product code: FRO Dressing, Wound, Drug
Reason for recall: A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ConSeal sent an Urgent Medical Device Recall letter dated April 25, 2018, to its customers via email. The letter instructed customers to locate the affected product, quarantine, and return it to the firm. Customers were also instructed to complete and return the customer response form, and inform any users the customer distributed the product to. Customers may contact the firm by calling 782-352-0490. For further questions, please call (781) 278-0010.
Quantity in commerce: 384
Distribution: US Distribution to the states of : AL, MS, and MA.
Product codes and lots: Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1627-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1627-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)