Welch Allyn Reusable Blood Pressure Cuff Kits Recalled for Undeclared Rubber
Baxter Healthcare Corporation is recalling Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits worldwide due to undeclared natural rubber in the packaging. Consumers with latex allergies may experience allergic reactions if exposed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is a Class II medical device recall involving allergen mislabeling (undeclared natural rubber/latex), which is a common and potentially serious allergen. No illnesses or injuries are reported in the source text, placing it at the high end of the allergen-mislabeling category per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling certain Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits distributed worldwide. The kits contain undeclared natural rubber within the packaging of certain configurations.
Individuals with latex or natural rubber allergies may experience allergic reactions if exposed to the rubber component during use or handling of the product.
Consumers who have purchased affected units should stop using the product if they have a known latex or natural rubber allergy and contact Baxter Healthcare Corporation or their healthcare provider for guidance on safe handling or replacement options.
For specific product codes and part numbers affected by this recall, including models 410519, 5090-41, and 5098-20, consumers should refer to the FDA recall notice (Z-1568-2025) or contact the manufacturer directly.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 76,407
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 # 47-15-389
- UDI/DI 00732094002423
- Product Code/Part # 47-22-189
- UDI/DI 00732094002379
- Product Code/Part # 47-23-189
- UDI/DI 00732094002362
- Product Code/Part # 5082-01
- UDI/DI 00732094113723
- Product Code/Part # 5082-01H
- UDI/DI 00732094113693
- Product Code/Part # 5082-02
- UDI/DI 00732094113679
- Product Code/Part # 5082-03
- UDI/DI 00732094113648
- Product Code/Part # 5082-07
- UDI/DI 00732094113631
- Product Code/Part # 5082-08
- UDI/DI 00732094113600
- Product Code/Part # 5082-11
- UDI/DI 00732094113327
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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