FDA Medical Device Recalls (openFDA)
Conseal International, Inc.: 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.
- Recall number
- Z-1627-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-04-25
- Posted
- not on file
- Terminated
- 2019-04-02
- Reason
- 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
- 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
- 384
- Distribution
- US Distribution to the states of : AL, MS, and MA.
- Lot, serial or model codes
- Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3004610547
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28