CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
3M Universal Electrosurgical Pad recalled by 3M Company - Health Care
3M Company - Health Care Business is recalling 3M Universal Electrosurgical Pad, distributed nationwide in the US. The recall was initiated on 26 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0701-2017
- FDA event ID
- 75644
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2016
- FDA classified
- 3 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 26 Oct 2016 | Recall initiated by company | |
| 3 Dec 2016 | Classified by FDA | +38 days |
| 14 Dec 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.
Nationwide ArkansasArizonaCaliforniaFloridaGeorgiaIdahoIllinoisKentuckyNorth CarolinaNew YorkTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product REF 9130 Lot Numbers: 2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration 03-2019) Product REF 9735-LP Lot Numbers: 2019-02DB and 2019-02CY. (Both with Expiration 02-2019)
Where was it sold?
Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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