The Recall Desk
HighFDA (Devices)·Z-1565-2025·Announced 2025-04-23

Blood pressure cuff devices recalled for undeclared natural rubber allergen

Baxter Healthcare Corporation is recalling Welch Allyn Spot Vital Signs 4400 blood pressure cuff devices due to an undeclared natural rubber band in the packaging that could trigger allergic reactions in latex-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: This recall addresses an undeclared common allergen—natural rubber/latex—present in product packaging. Per FDA Class II medical device recall criteria, allergen mislabeling on common allergens without reported illness warrants a High (3) severity classification. No illnesses or injuries have been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling Welch Allyn Spot Vital Signs 4400 blood pressure cuff devices (product codes 44WT-2, 44WT-3, 44WT-4, 44WT-6, 44WT-B, 44XT-2, 44XT-4, 44XT-6, and 44XT-B) due to an undeclared natural rubber band in the packaging of certain configurations. Natural rubber can trigger allergic reactions in persons with latex sensitivity.

Approximately 34,187 units have been distributed worldwide, including lot number 24-314 and lower.

Consumers should contact Baxter Healthcare Corporation for replacement or return instructions if they have affected devices. The devices should not be used if there is any risk of exposure to persons with known latex allergies.

The recalled product

Product
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Vital Signs Monitor / Blood Pressure Measurement
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 (19)

  • 1) Product Code/Part # 44WT-2
  • UDI/DI 00732094309461
  • 2) Product Code/Part # 44WT-3
  • UDI/DI 00732094309454
  • 3) Product Code/Part # 44WT-4
  • UDI/DI 00732094309447
  • 4) Product Code/Part # 44WT-6
  • UDI/DI 00732094309423
  • 5) Product Code/Part # 44WT-B
  • UDI/DI 00732094309409
  • 6) Product Code/Part # 44XT-2
  • UDI/DI 00732094309386
  • 7) Product Code/Part # 44XT-4
  • UDI/DI 00732094309362
  • 8) Product Code/Part # 44XT-6
  • UDI/DI 00732094309348
  • 9) Product Code/Part # 44XT-B
  • UDI/DI 00732094309324
  • Lot Number 24-314 & lower

Distribution

Distribution scope not specified by the agency.

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