Agency classClass IIOur severity:Severe FDA (Devices)·Z-1560-2025·Announced 2025-04-23

Welch Allyn CP150 Electrocardiograph Recall Due to Battery Fire Risk

Baxter Healthcare is recalling Welch Allyn CP150 Electrocardiographs worldwide due to reports of battery-related fires. The fires occurred when devices used non-approved, third-party aftermarket batteries.

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: This is an FDA Class II recall involving a medical device with reports of fire hazard. Fire risk represents a significant safety hazard with potential for serious injury, meeting the Severe criterion.

Plain-English summary

Baxter Healthcare Corporation is recalling the Welch Allyn CP150 Electrocardiograph due to customer reports of battery-related fires. Investigation determined that affected devices were utilizing third-party, aftermarket batteries that are not approved by Baxter.

The recalled product is distributed nationwide in the United States and worldwide. Approximately 41,739 units are affected, encompassing multiple product codes and UDI-DI identifiers in various language configurations.

Users of affected devices should discontinue use of any non-approved, aftermarket batteries and contact Baxter Healthcare or their local representative for guidance on approved battery options. Consumers with questions should reach out to the manufacturer or contact the FDA for additional information.

The recalled product

Product: Welch Allyn CP150 Electrocardiograph:
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Electrocardiograph
Hazard: battery-fire
fire-hazard
Affected units: 41,739

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 (20)

All Serial Numbers. Product Code: CP150-2ES2
UDI-DI: 00732094192131
Product Code: CP150-2FR2
UDI-DI: 00732094192124
Product Code: CP150-2FR5
UDI-DI: 00732094192117
Product Code: CP150-2NL2
UDI-DI: 00732094192100
Product Code: CP150-2PT2
UDI-DI: 00732094192087
Product Code: CP150-2SV2
UDI-DI: 00732094192070
Product Code: CP150-3ENB
UDI-DI: 00732094179705
Product Code: CP150-3ESB
UDI-DI: 00732094179682
Product Code: CP150-4DE2
UDI-DI: 00732094192063
Product Code: CP150-4EN2
UDI-DI: 00732094179675

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation 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 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · battery fire