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Lower risk Medical device recall · FDA · Published December 28, 2020

Baxter Flow Coupler Monitor Devices: Battery Recharge Issues

Baxter recalls 5-size Flow Coupler Monitor devices with potential battery recharge issues. Affected units have specific serial numbers and sizes. No remedy stated in recall.

🇺🇸 FDA recall #Z-0939-2021Medical deviceBaxter ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter is recalling Flow Coupler Monitor devices that come in 5 sizes. These implantable medical devices may lose their ability to be recharged, which could affect their function. This recall does not include a remedy. Read more at govinfonow.com/recall/63592-baxter-flow-coupler-monitor-devices-battery-recharge-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/63592-baxter-flow-coupler-monitor-devices-battery-recharge-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0939-2021

Cite this page

“Baxter Flow Coupler Monitor Devices: Battery Recharge Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63592-baxter-flow-coupler-monitor-devices-battery-recharge-issues. Based on FDA recall #Z-0939-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0939-2021%22&limit=1).

Why it’s dangerous

The battery in these devices may lose its ability to be recharged over time. This could lead to the device not functioning properly during medical procedures. However, the recall does not specify how this affects patient safety directly.

Who’s affected

Patients using Baxter Flow Coupler Monitor devices for vascular procedures may be affected. Those with specific serial numbers listed in the recall are most at risk.

How to tell if you have this one

Check if your device has a serial number from the list provided in the recall (e.g., 135306000279 to 139609000610). The device comes in 5 sizes: 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm.

  • Brand
    Baxter
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the serial number on your device to see if it matches the list of affected numbers provided in the recall.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 42 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Dec 28, 202012. FDA classified it Class II: Jan 30, 202123. Published in FDA’s Enforcement Report: Feb 10, 2021320202021
  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.

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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-0939-2021 (December 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0939-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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