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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84272

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 14, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Radiofrequency Grounding Pad, REF RF-DGP-L

Z-0664-2020
Recall number
Z-0664-2020
Initiated
October 14, 2019
Classification
Class II
Status
Terminated
Recalling firm
Abbott Medical
Quantity
8940 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021

Distribution pattern

nationwide