The Recall Desk
HighFDA (Devices)·Z-1819-2020·Announced 2020-05-06

Welch Allyn ECG Lead Sets Recalled for Defibrillation Safety Non-Compliance

Welch Allyn is recalling 78,521 ECG lead sets because they may not meet defibrillation withstand safety requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm from a medical device failing to meet safety standards, with no reported injuries or illnesses.

Plain-English summary

Welch Allyn, Inc/Mortara is recalling 78,521 replaceable lead sets for the Wireless Acquisition Module (WAM) and other Electrocardiographs. The affected products include various 10-wire and 13-wire lead sets with banana or clip connectors, sold under multiple model numbers.

The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of the EN/IEC 60601-2-25 standard for Medical Electrical Equipment. This standard ensures that medical devices can safely withstand defibrillation procedures without causing harm to the patient or malfunctioning.

The products were distributed nationwide in the United States, including all 50 states, the District of Columbia, Puerto Rico, and Ontario. Healthcare facilities and users should stop using the affected lead sets and contact Welch Allyn for further instructions on replacement or repair.

The recalled product

Product
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA G
Manufacturer
WELCH ALLYN, INC/MORTARA
Category
Medical Device — ECG Lead Sets
Hazard
Affected units
78,521

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model Numbers: 9293-046-60 - 9293-047-71
  • 9293-017-50 - 9293-017-51
  • 9293-026-50 - 9293-026-51
  • 9293-061-50 - 9293-061-53
  • 9293-033-52 - 9293-033-53 and 9293-034-50.

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by WELCH ALLYN, INC/MORTARA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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