Guardian Real-Time Monitor
Medical device recall Z-2442-2015. Published in FDA’s Enforcement Report on Sep 2, 2015.
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 Sep 2, 2015. Copied from openFDA on Oct 24, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 254 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?
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
254 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U KIT207482U KIT207495U KIT209292U KIT209308U KIT209282U KIT209297U KIT207481U KIT207491U KIT207494U KIT209284U KIT227732U…
Every code shown here, 1,991 characters
GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U KIT207482U KIT207495U KIT209292U KIT209308U KIT209282U KIT209297U KIT207481U KIT207491U KIT207494U KIT209284U KIT227732U KIT227735U KIT227740U KIT227746U KIT229227U KIT229224U KIT237462U KIT207486U KIT241304U KIT241308U KIT241292U KIT242887U KIT210467U KIT210465U KIT242885U KIT242888U KIT242890U KIT242893U KIT210485U KIT254775U KIT254779U KIT247924U KIT258441U KIT249491U KIT263472U KIT226461U KIT258451U KIT249497U KIT249498U KIT259531U KIT265811U KIT258445U KIT267592U KIT267602U KIT255788U KIT267584U KIT267573U KIT267597U KIT267576U KIT267599U KIT265806U KIT259534U KIT265804U KIT270748U KIT270754U KIT270759U KIT269538U KIT269540U KIT269535U KIT270765U KIT270767U KIT270769U KIT270773U KIT273802U KIT280803U KIT280805U KIT280806U KIT280807U KIT280808U KIT280816U KIT286957U KIT280818U KIT280819U KIT280804U KIT300938U KIT300907U KIT300911U KIT300929U KIT300967U KIT300970U GLU118597U KIT309260U KIT309261U KIT309259U KIT309270U KIT309282U KIT311088U KIT311073U KIT311064U KIT311092U KIT311065U GLU118509U KIT312757U KIT312761U KIT312763U KIT312766U KIT312769U KIT312774U KIT312781U KIT321125U KIT323925U KIT323927U KIT321128U KIT323921U KIT329501U KIT328377U KIT328379U KIT328381U KIT329497U KIT322588U KIT323920U KIT326942U KIT326943U KIT326946U KIT326949U KIT326950U KIT311082U KIT311067U KIT311081U KIT326951U KIT326952U KIT331688U KIT331679U KIT307592U KIT352678U KIT352679U KIT352681U KIT352682U KIT352686U KIT352688U KIT352694U KIT346026U KIT346034U KIT346046U KIT346048U KIT346054U KIT346055U KIT352685U KIT352693U KIT346012U KIT331691U KIT354998U KIT364697U KIT364723U KIT364769U KIT364801U KIT364703U KIT364706U KIT364775U KIT364778U KIT364779U KIT364781U KIT364790U KIT364793U KIT364799U KIT364709U KIT364719U KIT354993U KIT364711U KIT369439U KIT369438U KIT369442U GLU120263U KIT367592U GLU118506U KIT355018U KIT355019U KIT355022U GLU121754U KIT369467U KIT369449U…
FDA’s list runs to 2,793 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.
Distributed in Finland.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 23, 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 Jul 22, 2015.
- FDA classified it on Aug 21, 2015.
- FDA’s Enforcement Report published it on Sep 2, 2015.
- FDA terminated it on Sep 18, 2015.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Who is recalling it?
- Medtronic MiniMed Inc., of Northridge, CA.
- 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 23, 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 2,793 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 23, 2026 and checked Oct 23, 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 24, 2026.