Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part… recallZ-1565-2025 · Baxter Healthcare Corporation · initiated Mar 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1565-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 21, 2025
- Posted by the FDA
- Apr 15, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 34187 units
- Product code
- MWI
- FDA submissions
- K142356
- Distribution
- Worldwide distribution.
Product description
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Code information (models, lots, serial numbers)
1) Product Code/Part # 44WT-2, UDI/DI 00732094309461; 2) Product Code/Part # 44WT-3, UDI/DI 00732094309454; 3) Product Code/Part # 44WT-4, UDI/DI 00732094309447; 4) Product Code/Part # 44WT-6, UDI/DI 00732094309423; 5) Product Code/Part # 44WT-B, UDI/DI 00732094309409; 6) Product Code/Part # 44XT-2, UDI/DI 00732094309386; 7) Product Code/Part # 44XT-4, UDI/DI 00732094309362; 8) Product Code/Part # 44XT-6, UDI/DI 00732094309348; 9) Product Code/Part # 44XT-B, UDI/DI 00732094309324; Lot Number 24-314 & lower
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Welch Allyn, Inc. 901057Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall2 reports
- Welch Allyn, Inc. 901057Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under K142356 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Welch Allyn, Inc. 901001Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall5 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)1 recall1 report
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)1 recall0 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall0 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · Monitor, physiological, patient (without arrhythmia detection or alarms)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96364).
- Z-1562-2025 · Open, ClassifiedWelch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8)…
- Z-1563-2025 · Open, ClassifiedWelch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B…
- Z-1564-2025 · Open, ClassifiedWelch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B…
- Z-1566-2025 · Open, ClassifiedWelch 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) 777…
- Z-1567-2025 · Open, ClassifiedWelch 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…
- Z-1568-2025 · Open, ClassifiedWelch 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 B…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page