FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: 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.
- Recall number
- Z-1566-2025
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2025-03-21
- Posted
- 2025-04-15
- Terminated
- not on file
- Reason
- Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Root cause
- Device Design
- Action
- Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/21/2025 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate the impacted products (see Attachment A for details) at your facility that are unopened. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed Reply Form Instruction Sheet, even if you have no remaining inventory. 3. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for the return and exchange of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Director of Nursing, and any other departments within your institution who unpack the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) and you have an affected product please do not distribute. Contact Baxter Technical Support for additional instructions. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, please contact Baxter Technical Support between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday at 800-535-6663. Press option 2, then select option 1 or 2 for language preference, then press option 2.
- Quantity
- 135 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28