Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 5, 2012
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradati…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalled DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containin… - a moderate-severity action.
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containin… was recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) in September 5, 2012. Reason: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads a…. Check the official notice for the remedy. Verify recall #Z-2301-2012 with the FDA Devices before acting.
The recall
Nellcor Puritan Bennett Inc. (dba Covidien LP) issued this moderate-severity FDA Devices recall-Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads a….
- Moderate
- severity level
- 185K units
- affected scope
- Class II
- classification
- September 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2301-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2301-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on August 1, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Nellcor Puritan Bennett Inc. (dba Covidien LP) is listed as the recalling firm, operating out of Boulder, CO. Federal records list the affected scope as 184,934 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pa… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.. 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.
Medical Devices recalls over time
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.
Affected scope
184,934 units
Related Recalls
6
3 from same agency
Product description
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Reason for recall
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2301-2012 |
| Date reported | September 5, 2012 |
| Date initiated | August 1, 2012 |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Firm location | Boulder, CO |
| Affected scope | 184,934 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay. |
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.
- Check the recall number (Z-2301-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.. Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP). Units affected: 184,934 units.
Why was this product recalled? ▼
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2301-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2301-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 September 5, 2012. 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.