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Use caution Medical device recall · FDA · Published January 23, 2025

BD Pyxis MedFlex 2.0 Spare Parts: Fingerprint Scanner Heating Hazard

Recalled BD Pyxis MedFlex 2.0 spare parts (REF 353200-01) have fingerprint scanners that heat up due to failure, potentially causing burns. Affected units include specific serial numbers listed in the recall.

🇺🇸 FDA recall #Z-1207-2025Medical deviceBD CareFusion ›
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Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

What happened, in plain English

BD CareFusion is recalling Bio-ID spare parts for their Pyxis MedFlex 2.0 Automated Dispensing Cabinets. These parts can overheat from a faulty fingerprint scanner, posing a burn risk during normal use. Read more at govinfonow.com/recall/53038-bd-pyxis-medflex-2-0-spare-parts-fingerprint-scanner-heating.

Source Summary by GovInfoNow · govinfonow.com/recall/53038-bd-pyxis-medflex-2-0-spare-parts-fingerprint-scanner-heating · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1207-2025

Cite this page

“BD Pyxis MedFlex 2.0 Spare Parts: Fingerprint Scanner Heating Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53038-bd-pyxis-medflex-2-0-spare-parts-fingerprint-scanner-heating. Based on FDA recall #Z-1207-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1207-2025%22&limit=1).

Why it’s dangerous

The fingerprint scanner in these spare parts fails, causing it to heat up. This overheating can lead to burns during normal use when the scanner is activated for access control.

Who’s affected

Healthcare facilities using the Pyxis MedFlex 2.0 system with the specified spare parts (REF 353200-01) are most at risk. Patients and staff could experience burns if the scanner overheats.

How to tell if you have this one

Check if your Pyxis MedFlex 2.0 cabinet has spare part catalog number 353200-01. Affected units include specific serial numbers listed in the recall notice.

  • Brand
    BD CareFusion
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Serial Numbers

    Review the list of affected serial numbers provided in the recall notice to confirm if your unit is included.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 43 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: 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: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: 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: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Jan 23, 202512. FDA classified it Class II: Feb 21, 202523. Published in FDA’s Enforcement Report: Mar 5, 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

Do I need to stop using this part immediately?

No, but you should check if your unit is affected before using it. The recall does not require immediate removal.

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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-1207-2025 (January 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1207-2025 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