The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1558-2025·Announced 2025-04-23

Welch Allyn Connex Vital Signs Monitors with Unapproved Batteries

Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitors because some units experienced battery-related fires caused by unapproved third-party after-market 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 of a medical device with reports of fire—a significant safety hazard that poses risk of property damage and potential patient harm. Although no injuries or hospitalizations are explicitly stated in the source, the fire hazard represents a material risk warranting a Severe classification.

Plain-English summary

Baxter Healthcare Corporation is recalling approximately 228,412 units of the Welch Allyn Connex Vital Signs Monitor (CVSM) due to reports of battery-related fires. The investigation determined that affected devices were using third-party, after-market batteries that are not approved by Baxter.

The recalled devices are distributed worldwide, including nationwide in the US. Affected product codes and UDI-DI numbers span multiple models and variants of the Connex CVSM product line. All serial numbers of the affected product codes are included in this recall.

Patients and healthcare facilities should immediately cease use of recalled devices and contact Baxter Healthcare for instructions on device replacement or repair. Do not use unapproved third-party or after-market batteries in Connex Vital Signs Monitors.

The recalled product

Product
Welch Allyn Connex Vital Signs Monitor (CVSM):
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Vital Signs Monitor
Hazard
Affected units
228,412

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: 67MCTX-4
  • UDI-DI: 00732094193787
  • Product Code: 67MCTX-6
  • UDI-DI: 00732094194654
  • Product Code: 67MCTX-B
  • UDI-DI: 00732094151367
  • Product Code: 67MCXP-B
  • UDI-DI: 00732094151350
  • Product Code: 67MCXX-B
  • UDI-DI: 00732094151343
  • Product Code: 67MREP-B
  • UDI-DI: 00732094151336
  • Product Code: 67MREX-B
  • UDI-DI: 00732094151329
  • Product Code: 67MRTP-B
  • UDI-DI: 00732094151312
  • Product Code: 67MRTX-B
  • UDI-DI: 00732094151305
  • Product Code: 67MRXP-4
  • UDI-DI: 00732094193640

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 →

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