Conseal International, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1627-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 25, 2018

Date Posted: May 9, 2018

Recall Number: Z-1627-2018

Event ID: 79962

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.

Status: Terminated

Product Quantity: 384

Code Information:

Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.

Distribution Pattern:

US Distribution to the states of : AL, MS, and MA.

Voluntary or Mandated:

Voluntary: Firm initiated