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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75644

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

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Event summary

Timeline bucket
October 26, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

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.

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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

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.

Z-0701-2017
Recall number
Z-0701-2017
Initiated
October 26, 2016
Classification
Class II
Status
Terminated
Quantity
32,000 pads

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

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Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.