Alaris Infusion Pump Module
Medical device recall Z-2204-2021. Published in FDA’s Enforcement Report on Aug 18, 2021.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 18, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 9 states named in where it went
- 718 potentially affected pumps how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, 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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
718 potentially affected pumps, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 13414138 13414659 13414829 13415843 15221825 15221825 12744341 12835089 12861990 12875918 12959808 13077410 13077413 13077474 13681407 15306396 15306899 12420646 12421169 12635894 12781498 12949510 13367664 13415216…
Every code shown here, 2,000 characters
Serial Numbers: 13414138 13414659 13414829 13415843 15221825 15221825 12744341 12835089 12861990 12875918 12959808 13077410 13077413 13077474 13681407 15306396 15306899 12420646 12421169 12635894 12781498 12949510 13367664 13415216 13931954 2000189 3000595 3000883 3060800 3114560 3163062 3169497 3704252 3704268 3704322 3704343 3704366 3704476 3704477 3704485 3704529 3704536 3704549 3704639 3704645 3704810 3704814 3704853 4109720 4110277 8000560 9885878 9923593 9923615 9923671 9923800 9928207 13900270 13895113 13895704 10938662 12335127 12356902 12357956 12371188 12377005 12377451 12377463 12377633 12377809 12377870 12378093 12378095 12378248 12378686 12379004 12435805 12447105 12447140 12447792 12447797 12447834 12447943 12457014 12527904 12534361 12558945 12559059 12560637 12569213 12609470 12609853 12610581 12610619 12610636 12610848 12611472 12612154 12612168 12612237 12612426 12612541 12612616 12612728 12612766 12613011 12613031 12613120 12613277 12613768 12613837 12613890 12619413 12619529 12619951 12622026 12624268 12624491 12634090 12634406 12634579 12635091 12635338 12637040 12637223 12638709 12639158 12639193 12639297 12639360 12641568 12642114 12642164 12642181 12796265 12796791 12827297 12827661 12865629 12896173 13077488 13135729 13136085 13154391 13167829 13161437 13161735 13161788 13161807 13161813 13161815 13161976 13162084 13162132 13162134 13162171 13162181 13162192 13162193 13162199 13162288 13162296 13162297 13162306 13162314 13162316 13162318 13162339 13162345 13162399 13162403 13162408 13162409 13162411 13162412 13162436 13162437 13162440 13162450 13162451 13162455 13162458 13162473 13162480 13162482 13162483 13162486 13162488 13162491 13162498 13162499 13162514 13162550 13162649 13162678 13162680 13162685 13162715 13162724 13162725 13162730 13162740 13162741 13162742 13162743 13162744 13162758 13162760 13162762 13162765 13162766 13162767 13162770 13162772 13162774 13162777 13162779 13162780 13162782 13162785 13162792 13162802 13162803 13162806…
FDA’s list runs to 6,316 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.
The states and territories these words name
- California
- Illinois
- Indiana
- Kentucky
- Louisiana
- New Jersey
- Nevada
- Ohio
- Pennsylvania
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 25, 2021.
- FDA classified it on Aug 6, 2021.
- FDA’s Enforcement Report published it on Aug 18, 2021.
- FDA terminated it on Apr 22, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BioMedical Equipment Service Co (BMES), of Louisville, KY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,316 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.