NelDerm Hydrogel Dressing — Class II medical device recall Z-2083-2020
Ongoing recall by Nelson Innovaions, Llc, reported 2020-05-27, distributed in CA, NC, PR. Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
| Recall number | Z-2083-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nelson Innovaions, Llc, Strongsville, OH, United States |
| Recall initiated | 2020-02-11 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Distributed | CA, NC, PR |
| Quantity | 100 units |
| Reason classes | foreign material |
| Lot numbers | 90971 |
Product
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Reason for recall
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2083-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.