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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Welch Allyn Replacement Bladder Kits Recalled Due to Sizing Error

Agency Publication Date: December 1, 2025
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Summary

Baxter Healthcare Corporation has recalled 118 units of the Welch Allyn INF BAG Thigh 1-Tube replacement bladder kit (Model REF 5089-18). These kits, designed as replacement parts for two-piece blood pressure cuffs, may contain a Large Adult size bladder instead of the intended Thigh size bladder. Because these kits are packaged with the incorrect size, healthcare providers may inadvertently use the wrong bladder for a patient's leg size.

Risk

Using an incorrectly sized blood pressure bladder can lead to inaccurate measurements, such as falsely low or high blood pressure readings. These errors can result in a clinician failing to recognize a serious medical condition or providing unnecessary treatment based on faulty data.

What You Should Do

  1. This recall affects Welch Allyn INF BAG replacement bladder kits for Thigh size 1-tube blood pressure cuffs, identified as Model REF 5089-18.
  2. Check the lot number and UDI-DI (00732094110845) printed on the replacement kit packaging to see if your supply is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled replacement bladder kits immediately and remove them from your clinical inventory.
  4. Contact Baxter Healthcare Corporation or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Welch Allyn INF BAG, Thigh 1-Tube Replacement Bladder
Variants: Thigh size
Model / REF:
5089-18
Lot Numbers:
23-296
23-318
23-325
23-353
24-008
24-036
24-037
24-138
24-183
25-037
25-112
25-119
25-180
UDI:
00732094110845

Product is a replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97926
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation; Authorized medical distributors
Manufactured In: United States
Units Affected: 118 units
Distributed To: California, Colorado, Ohio, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.