Agency classClass IIOur severity:Severe FDA (Devices)·Z-0701-2017·Announced 2016-12-14

3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect

3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a defect with the potential to cause patient burns, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.

Plain-English summary

3M Company - Health Care Business is recalling 3M Universal Electrosurgical Pads, specifically REF 9130 and REF 9135-LP. The recall involves 32,000 pads distributed worldwide, including in the United States, Canada, Chile, Costa Rica, Germany, Japan, Mexico, and South Africa.

The recall was initiated due to a report of an unintended material, identified as a process liner, within the product. This defect may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. Consequently, the defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site on the body.

Healthcare facilities and distributors should stop using the affected lots immediately. The affected lot numbers for REF 9130 are 2019-02DT and 2019-03DU, and for REF 9135-LP are 2019-02DB and 2019-02CY. All affected lots have expiration dates of 02-2019 or 03-2019.

The recalled product

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…
Manufacturer: 3M Company - Health Care Business
Category: Medical Device — Surgical Instruments
Hazard: burn-injury
defective-material
Affected units: 32,000

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · 3M Company - Health Care Business

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