Device recall

Z-1568-2025: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN…

FDA device recall · Class II · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-1568-2025
Recall event 96364
Product Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Product code DXQ
Recalling firm Baxter Healthcare Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K070060
FEI number 1417572

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)