DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA… — Class II medical device recall Z-2301-2012
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2012-09-05, distributed nationwide. Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads an
| Recall number | Z-2301-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2012-08-01 |
| Classified | 2012-08-29 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, FR, JP, MX, PA, SG, UY |
| Quantity | 184,934 units |
| Reason classes | specification failure |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2301-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.