The Recall Desk
HighFDA (Devices)·Z-1564-2025·Announced 2025-04-23

Welch Allyn Connex Vital Signs Monitor Recalled for Undeclared Natural Rubber

Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitors (40,166 units across multiple configurations) due to undeclared natural rubber bands in the packaging. The undeclared allergen poses a risk to individuals with natural rubber latex allergies.

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: This recall involves allergen mislabeling of a common allergen (natural rubber latex) on a medical device. Per the severity rubric, allergen mislabeling on common allergens without reported illness scores 3 (High). No illnesses or injuries have been reported in the source material.

Plain-English summary

Baxter Healthcare Corporation is recalling certain configurations of the Welch Allyn Connex Vital Signs Monitor due to the presence of undeclared natural rubber bands within the packaging. The recall affects 40,166 units with 41 different product codes and part numbers distributed worldwide.

The hazard stems from natural rubber bands that are not declared on the packaging or product labeling. Natural rubber latex is a known allergen that can trigger allergic reactions in sensitive individuals. This poses a risk in healthcare settings where these vital signs monitors are used, as staff and patients may have undiagnosed or known latex allergies and could be exposed through direct contact with the packaging.

Consumers and healthcare facilities using these monitors should inspect their packaging and contact Baxter Healthcare Corporation for guidance on replacement or remediation. Individuals with known natural rubber or latex allergies who have handled the affected products should seek medical attention if they experience allergic symptoms.

The recalled product

Product
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/P
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Vital Signs Monitor
Hazard
  • allergen-latex
  • undeclared-allergen

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)

  • 1) Product Code/Part # 67MXTP-B-ECG3A
  • UDI/DI 00732094323788
  • 2) Product Code/Part # 67MXTX-B
  • UDI/DI 00732094151244
  • 3) Product Code/Part # 67MXXP-B
  • UDI/DI 00732094151237
  • 4) Product Code/Part # 67MXXX-B
  • UDI/DI 00732094151220
  • 5) Product Code/Part # 67NCTP-B
  • UDI/DI 00732094151190
  • 6) Product Code/Part # 67NCTP-B-ECG3A
  • UDI/DI 00732094323771
  • 7) Product Code/Part # 67NCTX-B
  • UDI/DI 00732094151183
  • 8) Product Code/Part # 67NXEX-B
  • UDI/DI 00732094151145
  • 9) Product Code/Part # 67NXTP-B
  • UDI/DI 00732094151138
  • 10) Product Code/Part # 67NXTP-B-ECG3A
  • UDI/DI 00732094323764

Distribution

Distribution scope not specified by the agency.

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