The Recall Desk
HighFDA (Devices)·Z-1562-2025·Announced 2025-04-23

Welch Allyn Connex Wall System blood pressure cuffs recalled for undeclared rubber

Baxter Healthcare is recalling certain Welch Allyn Connex Integrated Wall System blood pressure cuff configurations due to an undeclared natural rubber band in the packaging that may cause allergic reactions in individuals with latex sensitivity.

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 is an FDA Class II recall involving allergen mislabeling (undeclared natural rubber/latex), which meets the High severity threshold for common allergen mislabeling without reported illness yet. The hazard is known but no injuries have been reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling certain configurations of the Welch Allyn Connex Integrated Wall System due to the presence of an undeclared natural rubber band within the product packaging. The recall affects 72 product codes and part numbers, with lot numbers 24-314 and lower, distributed worldwide across 8233 units.

Individuals with natural rubber or latex allergies may experience allergic reactions upon contact with the undeclared rubber band during unpacking or handling of the device. The presence of an allergen not disclosed on the product labeling or documentation creates a risk of harm to susceptible users.

Healthcare facilities and users should immediately cease use of affected units and contact Baxter Healthcare Corporation for instructions on return or replacement. Anyone who has experienced an allergic reaction related to this product should seek appropriate medical attention.

The recalled product

Product
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVX
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Blood Pressure Monitoring
Hazard
  • allergen-latex
  • allergen-natural-rubber
  • 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 # 84MTVE2-4
  • UDI/DI 00732094350548
  • 2) Product Code/Part # 84MTVE2-6
  • UDI/DI 00732094350463
  • 3) Product Code/Part # 84MTVE2-B
  • UDI/DI 00732094349856
  • 4) Product Code/Part # 84MTVE2-US
  • UDI/DI 00732094350388
  • 5) Product Code/Part # 84MTVEC-6
  • UDI/DI 00732094058741
  • 6) Product Code/Part # 84MTVEC-B
  • UDI/DI 00732094058734
  • 7) Product Code/Part # 84MTVEP-B
  • UDI/DI 00732094119442
  • 8) Product Code/Part # 84MTVEX-4
  • UDI/DI 00732094198638
  • 9) Product Code/Part # 84MTVX2-4
  • UDI/DI 00732094350531
  • 10) Product Code/Part # 84MTVX2-6
  • UDI/DI 00732094350456

Distribution

Distribution scope not specified by the agency.

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