Covidien Kangaroo Connect Enteral Feeding Pump
Medical device recall Z-1648-2016. Published in FDA’s Enforcement Report on May 18, 2016.
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 May 18, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 223 units 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
223 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: AS1500000614 AS1500000615 AS1500000620 AS1500000621 AS1500000628 AS1500000630 AS1500000631 AS1500000633 AS1500000637 AS1500000638 AS1500000639 AS1500000640 AS1500000641 AS1500000643 AS1500000680 AS1500000681 AS1500000683…
Every code shown here, 1,992 characters
Serial Numbers: AS1500000614 AS1500000615 AS1500000620 AS1500000621 AS1500000628 AS1500000630 AS1500000631 AS1500000633 AS1500000637 AS1500000638 AS1500000639 AS1500000640 AS1500000641 AS1500000643 AS1500000680 AS1500000681 AS1500000683 AS1500000685 AS1500000686 AS1500000687 AS1500000694 AS1500000695 AS1500000696 AS1500000697 AS1500000698 AS1500000699 AS1500000702 AS1500000703 AS1500000814 AS1500000820 AS1500000823 AS1500000824 AS1500000826 AS1500000827 AS1500000828 AS1500000830 AS1500000831 AS1500000833 AS1500000836 AS1500000837 AS1500000839 AS1500000842 AS1500000843 AS1500000845 AS1500000847 AS1500000849 AS1500000850 AS1500000852 AS1500000854 AS1500000856 AS1500000857 AS1500000858 AS1500000859 AS1500000860 AS1500000861 AS1500000862 AS1500000863 AS1500000866 AS1500000869 AS1500000872 AS1500000873 AS1500000874 AS1500000875 AS1500000876 AS1500000880 AS1500000883 AS1500000885 AS1500000887 AS1500000889 AS1500000891 AS1500000892 AS1500000894 AS1500000895 AS1500000896 AS1500000897 AS1500000898 AS1500000901 AS1500000902 AS1500000903 AS1500000904 AS1500000906 AS1500000907 AS1500000909 AS1500000911 AS1500000912 AS1500000913 AS1500000915 AS1500000916 AS1500000917 AS1500000921 AS1500000922 AS1500000923 AS1500000924 AS1500000925 AS1500000926 AS1500000927 AS1500000928 AS1500000929 AS1500000930 AS1500000932 AS1500000933 AS1500000934 AS1500000935 AS1500000936 AS1500000941 AS1500000942 AS1500000947 AS1500000948 AS1500000951 AS1500000952 AS1500000955 AS1500000970 AS1500000974 AS1500000975 AS1500000976 AS1500000977 AS1500000978 AS1500000979 AS1500000981 AS1500000996 AS1500000998 AS1500001002 AS1500001009 AS1500001044 AS1500001045 AS1500001058 AS1500001061 AS1500001069 AS1500001075 AS1500001084 AS1500001125 AS1500001134 AS1500001137 AS1500001145 AS1500001146 AS1500001148 AS1500001149 AS1500001151 AS1500001158 AS1500001163 AS1500001166 AS1500001171 AS1500001172 AS1500001175 AS1500001178 AS1500001180 AS1500001182 AS1500001188 AS1500001190 AS1500001191 AS1500001192 AS1500001199…
FDA’s list runs to 2,914 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.
Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
These words name no state.
The words say it went outside the United States too.
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 Apr 1, 2016.
- FDA classified it on May 10, 2016.
- FDA’s Enforcement Report published it on May 18, 2016.
- FDA terminated it on May 18, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic, of North Haven, CT.
- 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 2,914 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.