Quick Facts at a Glance
- Recall Date
- October 28, 2025
- Hazard Level
- HIGH
- Brand
- Baxter Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Baxter Healthcare
- Product type
- Blood Pressure Cuff Replacement Bladder
- Model numbers
- UDI- DI 00732094110845, Lot Numbers: 23-296, 23-318, 23-325, 23-353, 24-008, 24-036, 24-037 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 28, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The Welch Allyn INF BAG is a replacement bladder for the two-piece reusable blood pressure cuff, commonly used in healthcare settings for accurate blood pressure monitoring. Healthcare providers and patients typically use this device to ensure proper readings during medical assessments.
Why This Is Dangerous
The hazard arises when the replacement bladder is mistakenly replaced with a Large Adult size bladder instead of the designated Thigh size bladder. This can lead to incorrect blood pressure measurements, potentially affecting patient diagnosis and treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should be aware of the potential for inaccurate blood pressure readings, which could compromise patient health. Immediate action is necessary to prevent any adverse health effects.
Practical Guidance
How to identify if yours is affected
- Check the model number on the bladder; it should be REF 5089-18.
- Confirm the bladder received is indeed the Thigh size and not the Large Adult size.
Where to find product info
The model number and lot numbers can typically be found printed on the bladder itself or on the packaging.
What timeline to expect
Refund processing may take approximately 4-6 weeks once the manufacturer receives the returned product.
If the manufacturer is unresponsive
- Contact Baxter Healthcare's customer service line directly.
- Document all correspondence and attempts to reach the company.
How to prevent similar issues
- Always verify the size of the bladder before use.
- Ensure compatibility with the blood pressure cuff model being used.
- Consult with healthcare providers for recommendations on reliable brands.
Documentation advice
Keep copies of all correspondence with the manufacturer and document the return process, including shipping receipts.
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Product Details
The recall affects the Welch Allyn INF BAG, Thigh 1-Tube, Model REF 5089-18. Sold nationwide in California, Colorado, Ohio, and Utah, this product is part of a replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff.
Key Facts
- Sold in California, Colorado, Ohio, and Utah
- Immediate stop-use required
- Contact Baxter Healthcare for instructions
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