Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    1) Product Code/Part # 5098-02, UDI/DI 00732094110128; Product Code/Part # 5098-23, UDI/DI 00732094109900; Product Code/Part # 5098-27, UDI/DI 00732094109856; Product Code/Part # 5098-28, UDI/DI 00732094109801; Product Code/Part # 5098-29, UDI/DI 00732094109764; Product Code/Part # 5098-30, UDI/DI 00732094109726; Product Code/Part # 5098-33, UDI/DI 00732094109658; Product Code/Part # 5098-42, UDI/DI 00732094109603; Product Code/Part # DS44-09, UDI/DI 00732094085884; Product Code/Part # DS44-11, UDI/DI 00732094085631; Product Code/Part # DS44-11C, UDI/DI 00732094085617; Product Code/Part # DS44-MC, UDI/DI 00732094084924; Product Code/Part # DS45-11, UDI/DI 00732094084610; Product Code/Part # DS45-11C, UDI/DI 00732094084498; Product Code/Part # DS45-12, UDI/DI 00732094084429; Product Code/Part # DS45-MC, UDI/DI 00732094083965; Product Code/Part # DS58-11, UDI/DI 00732094083385; Product Code/Part # DS58-MC, UDI/DI 00732094083347; Product Code/Part # DS58-PD, UDI/DI 00732094083309; Product Code/Part # DS58-ST, UDI/DI 00732094083170; 2) Product Code/Part Number 407637, UDI/DI 00732094046755; 3) Product Code/Part Number 7670-10,UDI/DI 00732094071511; Lot Number 24-314 & lower
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Baxter Healthcare Corporation
Reason for Recall:
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.

Product Codes/Lot Numbers:

1) Product Code/Part # 5098-02, UDI/DI 00732094110128; Product Code/Part # 5098-23, UDI/DI 00732094109900; Product Code/Part # 5098-27, UDI/DI 00732094109856; Product Code/Part # 5098-28, UDI/DI 00732094109801; Product Code/Part # 5098-29, UDI/DI 00732094109764; Product Code/Part # 5098-30, UDI/DI 00732094109726; Product Code/Part # 5098-33, UDI/DI 00732094109658; Product Code/Part # 5098-42, UDI/DI 00732094109603; Product Code/Part # DS44-09, UDI/DI 00732094085884; Product Code/Part # DS44-11, UDI/DI 00732094085631; Product Code/Part # DS44-11C, UDI/DI 00732094085617; Product Code/Part # DS44-MC, UDI/DI 00732094084924; Product Code/Part # DS45-11, UDI/DI 00732094084610; Product Code/Part # DS45-11C, UDI/DI 00732094084498; Product Code/Part # DS45-12, UDI/DI 00732094084429; Product Code/Part # DS45-MC, UDI/DI 00732094083965; Product Code/Part # DS58-11, UDI/DI 00732094083385; Product Code/Part # DS58-MC, UDI/DI 00732094083347; Product Code/Part # DS58-PD, UDI/DI 00732094083309; Product Code/Part # DS58-ST, UDI/DI 00732094083170; 2) Product Code/Part Number 407637, UDI/DI 00732094046755; 3) Product Code/Part Number 7670-10,UDI/DI 00732094071511; Lot Number 24-314 & lower

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1567-2025

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