FDA Medical Device Recalls (openFDA)
Abbott Medical: Radiofrequency Grounding Pad, REF RF-DGP-L
- Recall number
- Z-0664-2020
- Recalling firm
- Abbott Medical
- Product
- Radiofrequency Grounding Pad, REF RF-DGP-L
- Status
- Terminated
- Initiated
- 2019-10-14
- Posted
- not on file
- Terminated
- 2021-07-19
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 8940 devices
- Distribution
- nationwide
- Lot, serial or model codes
- UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
- 510(k) numbers
- ["K111576"]
- PMA numbers
- not on file
- Product code
- GXD
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28