Radiofrequency Grounding Pad, REF RF-DGP-L recallZ-0664-2020 · Abbott Medical · initiated Oct 14, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.
Recall details
- Recall number
- Z-0664-2020
- Status
- Terminated
- Initiated by the company
- Oct 14, 2019
- Recalling firm
- Abbott Medical
- Quantity
- 8940 devices
- Product code
- GXD
- FDA submissions
- K111576
- Distribution
- nationwide
Product description
Radiofrequency Grounding Pad, REF RF-DGP-L
Code information (models, lots, serial numbers)
UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA RF-DGP-LSt. Jude Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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