Nimbus II Infusion System
Medical device recall Z-1286-2024. Published in FDA’s Enforcement Report on Apr 3, 2024.
- 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 Apr 3, 2024. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 52,328 total 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?
InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
52,328 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: Nimbus II PainPRO: UDI-DI 00817170020086, Lots AHZ081-190619096 AHZ081-200229480 AHZ081-2004171062 AHZ081-200517528 AHZ081-200714696 AHZ081-2009231440 AHZ081-201105480 AHZ081-201105360 AHZ081-201208288 AHZ081-2012081944…
Every code shown here, 1,987 characters
UDI-DI: Nimbus II PainPRO: UDI-DI 00817170020086, Lots AHZ081-190619096 AHZ081-200229480 AHZ081-2004171062 AHZ081-200517528 AHZ081-200714696 AHZ081-2009231440 AHZ081-201105480 AHZ081-201105360 AHZ081-201208288 AHZ081-2012081944 AHZ081-2012081944 AHZ081-2108141920 AHZ081-211123360 AHZ081-2111242568 AHZ081-22062072 A100G-170420044 A100G-170512429 AGZ049-170512429 AGZ049-170615116 AGZ049-170816391 AGZ049-170829480 AGZ049-1709071188 AGZ049-171027828 AGZ049-1712011824 AGZ049-171229744 AGZ049-1806091272 AGZ049-180626984 AGZ049-1809201152 AGZ049-1810241536 AGZ049-181102108 AGZ049-190104504 AGZ049-190104648 AGZ049-190314768 AGZ049-1903151440 AGZ049-190515480 AGZ049-190515960 AGZ049-1906271440 AGZ049-1907231776 AGZ049-190723360 AGZ049-190806144 AGZ049-190924504 AGZ049-191023480 AGZ049-1912161920 AGZ049-200102576 AGZ049-2002251632 AGZ049-200714960 AGZ049-200828960 AGZ049-2009241440 AGZ049-2011301920 AGZ049-2103231200 AGZ049-210324360 AGZ049-210422528 AGZ049-210809480 AGZ049-211121360 AGZ049-2111222136 AGZ049-2202064320 AGZ049-220207720 AGZ049-220629624 AGZ049-2208091920 AGZ049-2312141632 AGZ049-2312271440 AGZ049-2401081344; Nimbus II Flex: UDI-DI 00817170020093 Lots AGZ050-170621081 AGZ050-170622027 AGZ050-170623297 AGZ050-170829240 AGZ050-171027180 AGZ050-180402360 AGZ050-180517720 AGZ050-190527480 AGZ050-190813360 AGZ050-190910360 AGZ050-190924720 AGZ050-200114300 AGZ050-210219600; Nimbus II Plus: UDI-DI 00817170020161 Lots AJZ074-190215120 AJZ074-190513120 AJZ074-190722360 AJZ074-20010379 AJZ074-200417282 AJZ074-200604960 AJZ074-200903960 AJZ074-210219720 AJZ074-210303180 AJZ074-210325960 AJZ074-2111081200 AJZ074-2202072880 AJZ074-2206012640 AJZ074-2206213120 AJZ074-2208092040 AJZ074-2208092640; Nimbus II EpiD: UDI-DI 00817170020376 Lot ALZ103-200824420; Nimbus II EMS: UDI-DI 00817170020109 Lots AGZ057-170925120 AGZ057-171027300; HS-001 Nimbus Administration Set: 00817170020017 HS-002 Nimbus Administration Set: 00817170020048 HS-003 Nimbus Administration Set:…
FDA’s list runs to 2,123 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.
Domestic US distribution nationwide. No international distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 21, 2024.
- FDA classified it on Mar 28, 2024.
- FDA’s Enforcement Report published it on Apr 3, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- InfuTronix LLC, of Natick, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 2,123 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.