Welch Allyn Blood Pressure Gauge Sets Recalled for Undeclared Natural Rubber
Baxter Healthcare is recalling Welch Allyn DuraShock blood pressure cuff gauge sets worldwide because the packaging contains an undeclared natural rubber band.
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 FDA Class II recall involves an undeclared allergen (natural rubber) in product packaging. Although no illnesses or injuries have been reported, the presence of an undeclared known allergen poses a risk of harm to consumers with latex or rubber sensitivities.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 385,920 units of Welch Allyn DuraShock Aneroid Gauge Sets with Reusable Blood Pressure Cuffs worldwide. The recalled products include multiple model numbers and configurations, distributed globally.
The recall was initiated because certain configurations of the reusable blood pressure cuffs contain an undeclared natural rubber band within the packaging. Natural rubber is a known allergen that can cause reactions in individuals with allergies to latex or rubber. The undeclared presence of this material poses a potential health risk to consumers unaware of the allergen.
No injuries or illnesses have been reported to date. Consumers who have purchased these gauge sets and have known allergies to natural rubber or latex should discontinue use and contact Baxter Healthcare for a replacement or refund.
The recalled product
- Product
- 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-
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- allergen-latex
- undeclared
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 # 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
Distribution
Distribution scope not specified by the agency.
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