CLASS II ONGOING Device recall · Reported 27 May 2020 · FDA Enforcement Report
NelDerm Hydrogel Dressing (Dressing: ; Pad: ) Product #: HB66T recalled
Nelson Innovaions is recalling NelDerm Hydrogel Dressing (Dressing: ; Pad: ) Product #: HB66T, distributed in California, North Carolina, Puerto Rico. The recall was initiated on 11 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2083-2020
- FDA event ID
- 85343
- Recalling firm
- Nelson Innovaions, Strongsville, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2020
- FDA classified
- 21 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 11 Feb 2020 | Recall initiated by company | |
| 21 May 2020 | Classified by FDA | +100 days |
| 27 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
Where it was distributed
CA, NC, PR
Questions about this recall
Is NelDerm Hydrogel Dressing (Dressing: ; Pad: ) Product #: HB66T recalled?
Yes. Nelson Innovaions recalled NelDerm Hydrogel Dressing (Dressing: ; Pad: ) Product #: HB66T on 11 Feb 2020. The recall is Class II and its status is Ongoing. Recall number Z-2083-2020.
Why was it recalled?
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Which lots are affected?
Lot #90971
Where was it sold?
CA, NC, PR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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