The FDA announced on 2019-10-14 that Abbott Medical is recalling Radiofrequency Grounding Pads due to a manufacturing defect that may cause uneven heating. The agency issued recall number Z-0664-2020 for the Class II device.
How to tell if you have it
- Brand: Abbott Medical
- Product: Radiofrequency Grounding Pad, REF RF-DGP-L
- UDI: 05415067028914
- Batch Numbers: 810319004, 810319005, and 810319021
The hazard
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.
Context
GovInfoNow's records show Abbott Medical has 15 other recalls on record since 2019-11-11. Recent brand recalls include a 2026-05-12 software malfunction risk for the Merlin PCS 365 and a 2025-02-15 premature battery failure risk for the Aveir DR Leadless Pacemaker. Other recent recalls of similar products include Medline Convenience Kits Recall (2026-05-28) and Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23).