Severity
Moderate
FDA Devices recall · Reported December 18, 2019
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 o…
Abbott Medical recalled Radiofrequency Grounding Pad, REF RF-DGP-L - a moderate-severity action.
Radiofrequency Grounding Pad, REF RF-DGP-L was recalled by Abbott Medical in December 18, 2019. Reason: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempti…. Check the official notice for the remedy. Verify recall #Z-0664-2020 with the FDA Devices before acting.
The recall
Abbott Medical issued this moderate-severity FDA Devices recall-Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempti….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0664-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0664-2020) was formally reported on December 18, 2019, with the manufacturer initiating the action on October 14, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Medical is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 8940 devices.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
8940 devices
Related Recalls
6
3 from same agency
Radiofrequency Grounding Pad, REF RF-DGP-L
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0664-2020 |
| Date reported | December 18, 2019 |
| Date initiated | October 14, 2019 |
| Recalling firm | Abbott Medical |
| Firm location | Plymouth, MN |
| Affected scope | 8940 devices |
| Distribution | nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 18, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.