FDA Device recall Z-0664-2020
Radiofrequency Grounding Pad, REF RF-DGP-L
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Radiofrequency Grounding Pad, REF RF-DGP-L by Abbott Medical, citing affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0664-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-14 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Radiofrequency Grounding Pad, REF RF-DGP-L
Reason
Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
Identifiers
| code_info | UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0664-2020%22
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