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

Welch Allyn Connex Integrated Wall System Cuffs Recalled for Undeclared Natural Rubber

Baxter Healthcare is recalling 8,233 units of Welch Allyn Connex Integrated Wall System reusable blood pressure cuffs worldwide due to undeclared natural rubber bands in product packaging that may cause allergic reactions in sensitive individuals.

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: FDA Class II recall involving an undeclared natural rubber allergen in product packaging. With no reported illnesses or injuries and the allergen present in packaging rather than the medical device itself, this meets the High severity threshold for allergen-related risk-of-harm products.

Plain-English summary

Baxter Healthcare Corporation is recalling 8,233 units of the Welch Allyn Connex Integrated Wall System reusable blood pressure cuffs that have been distributed worldwide. The affected units include multiple product configurations with specific product codes and lot number 24-314 or earlier.

The recalled units contain an undeclared natural rubber band within the product packaging. For individuals with allergies or sensitivities to natural rubber or latex, this undeclared allergen presents a hazard during handling and unpacking of the equipment.

Affected facilities and individuals should verify their equipment against the provided list of recalled product codes and part numbers. Any units matching the recall criteria should not be used and should be set aside.

For complete product code listings, additional information, or questions about the recall, consult Baxter Healthcare Corporation or review the FDA's official recall notice.

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 — Patient Monitoring / Blood Pressure Measurement
Hazard
  • undeclared-allergen
  • natural-rubber-latex

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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