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

[pending] Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3)

Pending LLM rewrite. Source: FDA_DEVICE Z-1565-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

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 — Devices

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.

Related recalls

Same category