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

BMES Alaris Infusion Pump Module Model 8100: Bezel Repair Parts May Crack

BMES recalls Alaris Infusion Pump Module Model 8100 units serviced with non-original bezel repair parts. Cracking posts could cause infusion issues. Check serial numbers listed for affected units.

🇺🇸 FDA recall #Z-2204-2021Medical deviceBMES ›
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Contact the company

Recalling firmBioMedical Equipment Service Co (BMES)2709 S Park Rd · Louisville, KY 40219-3645
✎ GovInfoNow plain-language explainer

BMES is recalling Alaris Infusion Pump Module Model 8100 units that were serviced with non-original bezel repair parts. These parts may crack over time, leading to infusion problems like over-infusion or interruptions. Read more at govinfonow.com/recall/63226-bmes-alaris-infusion-pump-module-model-8100-bezel-repair-parts.

Source Summary by GovInfoNow · govinfonow.com/recall/63226-bmes-alaris-infusion-pump-module-model-8100-bezel-repair-parts · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2204-2021

Cite this page

“BMES Alaris Infusion Pump Module Model 8100: Bezel Repair Parts May Crack.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63226-bmes-alaris-infusion-pump-module-model-8100-bezel-repair-parts. Based on FDA recall #Z-2204-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2204-2021%22&limit=1).

The Food and Drug Administration announced on Feb. 25, 2021, that BioMedical Equipment Service Co (BMES) is recalling Alaris Infusion Pump Modules serviced with impacted bezel repair parts due to potential cracking or separation of posts. This defect may cause free flow, over infusion, under infusion, or interruption of infusion. Owners should contact BMES for a remedy.

How to tell if you have it

  • Brand: BMES
  • Product: Alaris Infusion Pump Module, Model 8100
  • Part: TIPA-8100-4410 bezel repair part
  • Quantity: 718 potentially affected pumps

The hazard

Bezel repair parts used to service and repair the infusion pump modules, not by the original manufacturer, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Context

GovInfoNow's records show that BD Alaris Pump Infusion Sets were recalled on Aug. 19, 2026, for performance data discrepancies that may cause inappropriate pump function.

How to tell if you have this one

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

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

What to do — step by step

  1. Check for Affected Serial Numbers

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

Where it went and when

Where it was distributed

Distributed in 9 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest 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: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Illinois, Indiana, Kentucky, Louisiana, Nevada, New Jersey, Ohio, Pennsylvania.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Feb 25, 202112. FDA classified it Class I: Aug 6, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Apr 22, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-2204-2021 (February 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2204-2021 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