Agency classClass IIOur severity:High FDA (Devices)·Z-1566-2025·Announced 2025-04-23

Welch Allyn Green Series 777 Blood Pressure Cuff Wall System Recall

Baxter Healthcare Corporation is recalling certain Welch Allyn Green Series 777 Wall System blood pressure cuffs due to undeclared natural rubber in packaging. The recall affects 135 units distributed worldwide.

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 an FDA Class II recall involving an undeclared allergen (natural rubber) on a medical device. The hazard creates a direct risk of harm to individuals with natural rubber allergies, and no reported illnesses are mentioned in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling certain configurations of the Welch Allyn Green Series 777 Wall System reusable blood pressure cuffs. The recall was initiated because the packaging contains an undeclared natural rubber band.

The affected product includes seven part numbers: 77791-2MP2X, 77791-2MP2XL, 77791-2MPX, 77791-2MPX-HS, 77791-2MPXL, 77796-2MPX, and 77796-2MPXL. Lot Number 24-314 and lower are involved. A total of 135 units have been distributed worldwide.

Individuals with natural rubber allergies may be at risk if exposed to the undeclared rubber component. Customers who have received these devices should discontinue use and contact Baxter Healthcare Corporation for instructions on returning the affected products.

The recalled product

Product: Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Patient Monitoring / Blood Pressure Measurement
Hazard: allergen-natural-rubber
undeclared-allergen
Affected units: 135

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 (15)

1) Product Code/Part # 77791-2MP2X
UDI/DI 00732094066890
2) Product Code/Part # 77791-2MP2XL
UDI/DI 00732094201833
3) Product Code/Part # 77791-2MPX
UDI/DI 00732094066876
4) Product Code/Part # 77791-2MPX-HS
UDI/DI 00732094231045
5) Product Code/Part # 77791-2MPXL
UDI/DI 00732094201826
6) Product Code/Part # 77796-2MPX
UDI/DI 00732094066289
7) Product Code/Part # 77796-2MPXL
UDI/DI 00732094184013
Lot Number 24-314 & lower

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.

See all 7 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · allergen natural rubber