3M Universal Electrosurgical Pad — Class II medical device recall Z-0701-2017
Terminated recall by 3M Company - Health Care Business, reported 2016-12-14, distributed nationwide. 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in t
| Recall number | Z-0701-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2016-10-26 |
| Classified | 2016-12-03 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CR, DE, JP, MX, ZA |
| Quantity | 32,000 pads |
| Lot numbers | 2019-02CY, 2019-02DB, 2019-02DT |
| Model numbers | 9130, 9135-LP, 9735-LP |
| Expiration dates | 2019-02, 2019-03 |
Product
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). 3M Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended application could lead to an unsafe condition.
Reason for recall
3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.
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-0701-2017. 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.