Z-2083-2020Class II

NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T

Name: Z-2083-2020 NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Creator: Nelson Innovaions, Llc
Published: 2020-02-11
License: https://open.fda.gov/license/

Nelson Innovaions, LLC / initiated 2020-02-11 / Open, Classified / root cause: manufacturing process

FDA source

Nelson Innovaions, Llc began a recall of NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T on 2020-02-11. FDA classified it as Class II and gives the reason as "Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2083-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-11
Posted: 2020-05-21
Recalling firm: Nelson Innovaions, LLC
Product: NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Product code: NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Reason for recall: Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Root cause tag: manufacturing process
FDA 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 in commerce: 100 units
Distribution: CA, NC, PR
Product codes and lots: Lot #90971

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2083-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code NAE

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)