FDA Medical Device Recalls (openFDA)
Nelson Innovaions, Llc: NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
- Recall number
- Z-2083-2020
- Recalling firm
- Nelson Innovaions, Llc
- Product
- NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
- Status
- Open, Classified
- Initiated
- 2020-02-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
- Root cause
- Process control
- Action
- Nelson Innovations, LLC contacted customers on 2/11/20 via phone call to state reason for recall, health risk and request return of affected product and provided call tags for pick-up of product.
- Quantity
- 100 units
- Distribution
- CA, NC, PR
- Lot, serial or model codes
- Lot #90971
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAE
- Firm FEI
- 3015524870
- Firm city
- Strongsville
- Firm state
- OH
- 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