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Use caution Medical device recall · FDA · Published March 25, 2021

The Biomed Guys Alaris Infusion Pump Module 8100 Recall: Bezel Repair Part Cracking Risk

The Biomed Guys recalls Alaris Infusion Pump Module Model 8100 serviced with non-original bezel repair parts. Cracking may cause infusion errors. Affected units have specific serial numbers.

🇺🇸 FDA recall #Z-1651-2021Medical deviceThe Biomed Guys ›
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Recalling firmThe Biomed Guys1865 Ashland City Rd Ste H · Clarksville, TN 37043-6455
✎ GovInfoNow plain-language explainer

What happened, in plain English

The Biomed Guys is recalling Alaris Infusion Pump Module Model 8100 units that were serviced with non-original bezel repair parts. These parts may crack, leading to infusion errors like over-infusion or interruption of medication flow. This could cause serious harm to patients using the pump. Read more at govinfonow.com/recall/62952-the-biomed-guys-alaris-infusion-pump-module-8100-recall-bezel.

Source Summary by GovInfoNow · govinfonow.com/recall/62952-the-biomed-guys-alaris-infusion-pump-module-8100-recall-bezel · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1651-2021

Cite this page

“The Biomed Guys Alaris Infusion Pump Module 8100 Recall: Bezel Repair Part Cracking Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62952-the-biomed-guys-alaris-infusion-pump-module-8100-recall-bezel. Based on FDA recall #Z-1651-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2021%22&limit=1).

Why it’s dangerous

The non-original bezel repair part used during service may crack or separate. This can cause the pump to over-infuse or under-infuse medication, or stop the infusion entirely. These errors could lead to serious harm to patients.

Who’s affected

Patients using the Alaris Infusion Pump Module Model 8100 that were serviced by The Biomed Guys with the TIPA-8100-4410 bezel repair part are most at risk. The recall affects specific units with serial numbers listed in the notice.

How to tell if you have this one

Check if your Alaris Infusion Pump Module Model 8100 was serviced by The Biomed Guys using the TIPA-8100-4410 repair part. Affected units have specific serial numbers listed in the recall notice.

  • Brand
    The Biomed Guys
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

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

  2. Contact The Biomed Guys

    Reach out to The Biomed Guys directly to confirm if your pump was serviced with the impacted bezel repair part.

Where it went and when

Where it was distributed

Distributed in Indiana and Texas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Us distribution to the states of IN and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Indiana, Texas.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Mar 25, 202112. FDA classified it Class I: Jun 1, 202123. Published in FDA’s Enforcement Report: Jun 9, 202132021
  1. Firm started the recall
  2. FDA classified it Class I
  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-1651-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1651-2021 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