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Lower risk Medical device recall · FDA · Published October 28, 2025

Welch Allyn Thigh Blood Pressure Bladder Recall: Wrong Size Risk

Welch Allyn recalls replacement bladders for blood pressure cuffs that may be the wrong size, risking inaccurate readings. Affected units include specific model and lot numbers.

🇺🇸 FDA recall #Z-0847-2026Medical deviceWelch Allyn ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

What happened, in plain English

Welch Allyn is recalling replacement bladders for blood pressure cuffs that might be the wrong size (Thigh instead of Large Adult). This could lead to inaccurate blood pressure readings, which may affect health decisions. Read more at govinfonow.com/recall/50988-welch-allyn-thigh-blood-pressure-bladder-recall-wrong-size-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50988-welch-allyn-thigh-blood-pressure-bladder-recall-wrong-size-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0847-2026

Cite this page

“Welch Allyn Thigh Blood Pressure Bladder Recall: Wrong Size Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50988-welch-allyn-thigh-blood-pressure-bladder-recall-wrong-size-risk. Based on FDA recall #Z-0847-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2026%22&limit=1).

Why it’s dangerous

The replacement bladders might be the wrong size (Thigh instead of Large Adult), causing inaccurate blood pressure readings. This could lead to incorrect health decisions if the readings are used for medical purposes.

Who’s affected

People who own Welch Allyn blood pressure cuffs with the specific replacement bladder model REF 5089-18 and the listed lot numbers are affected. Those with the wrong size bladder may get inaccurate readings.

How to tell if you have this one

Check for the model number REF 5089-18 and lot numbers listed: 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.

  • Brand
    Welch Allyn
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Bladder Size

    Ensure the replacement bladder is labeled as 'Large Adult' for accurate blood pressure readings.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Ohio, Utah.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Oct 28, 202512. FDA classified it Class II: Dec 1, 202523. Published in FDA’s Enforcement Report: Dec 10, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of injury?

The recall addresses inaccurate readings, not physical injury. This is a low-risk issue.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0847-2026 (October 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0847-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA