FDA Medical Device Recalls (openFDA)
Kova Laboratories, Inc.: Amerigel Wound Dressing 1 oz. tube
- Recall number
- Z-1992-2014
- Recalling firm
- Kova Laboratories, Inc.
- Product
- Amerigel Wound Dressing 1 oz. tube
- Status
- Terminated
- Initiated
- 2014-03-21
- Posted
- 2014-07-04
- Terminated
- 2016-09-12
- Reason
- Product may not have been manufactured pursuant to a validated process protocol and CGMP.
- Root cause
- Process control
- Action
- Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned.
- Quantity
- 122,396 / 1oz. tubes
- Distribution
- Distributed in the states of FL and NJ.
- Lot, serial or model codes
- Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
- 510(k) numbers
- ["K971918"]
- PMA numbers
- not on file
- Product code
- MGQ
- Firm FEI
- 3005050034
- Firm city
- Margate
- Firm state
- FL
- 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