MRI LED Mobile Exam Light Battery
Medical device recall Z-1436-2026. Published in FDA’s Enforcement Report on Mar 4, 2026.
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 Mar 4, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 35 states named
- 314 batteries 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?
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
314 batteries, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: SL-111 UDI-DI code: Pending Information Serial/Lot Numbers: 23-12-074 23-12-039 0 2006001 2006002 2006004 2006005 2006006 2006007 2006008 2006009 2006011 2006012 2006013 2006014 2006015 2006016 2006017 2006018 2006020 2006021…
Every code shown here, 2,000 characters
Model Number: SL-111 UDI-DI code: Pending Information Serial/Lot Numbers: 23-12-074 23-12-039 0 2006001 2006002 2006004 2006005 2006006 2006007 2006008 2006009 2006011 2006012 2006013 2006014 2006015 2006016 2006017 2006018 2006020 2006021 2006023 2006024 2006026 2006027 2006028 2006029 2006030 2006031 2006031 2006032 2006033 2006034 2006035 2006038 2006039 2006040 2006043 2204028 2204047 2206001 2206003 2206004 2206005 2206006 2206009 2206010 2206011 2206012 2206013 2206014 2206015 2206016 2206017 2206018 2206019 2206020 2206021 2206022 2206024 2206026 2206027 2206029 2206030 2206033 2206034 2206036 2206037 2206038 2206040 2206042 2206043 2206044 2206045 2206046 2206048 2206049 2206050 2206052 2206053 2206054 2206055 2206056 2206057 2206058 2206059 2206060 2206062 2206063 2206064 2206065 2206066 2206067 2206068 2206069 2206070 2206071 2206072 2206073 2206074 2206075 2206076 2206077 2206079 2206080 2206081 2206082 2206083 2206084 2206085 2206086 2206087 2206088 2206090 2206092 2206093 2206094 2206095 2206096 2206097 2206098 2206099 2206100 2301228 2311040 2311058 2312001 2312002 2312003 2312004 2312005 2312006 2312007 2312008 2312009 2312010 2312011 2312012 2312013 2312014 2312015 2312016 2312018 2312019 2312020 2312021 2312022 2312023 2312024 2312025 2312026 2312027 2312029 2312030 2312031 2312033 2312034 2312035 2312036 2312036 2312037 2312038 2312039 2312041 2312041 2312042 2312044 2312045 2312047 2312049 2312050 2312051 2312052 2312053 2312054 2312055 2312056 2312057 2312058 2312059 2312060 2312061 2312062 2312064 2312065 2312066 2312067 2312068 2312070 2312071 2312072 2312074 2312075 2312076 2312077 2312078 2312079 2312080 2312080 2312081 2312082 2312082 2312083 2312084 2312087 2312089 2312090 2504001 2504003 2504004 2504005 2504006 2504007 2504008 2504010 2504011 2504013 2504014 2504015 2504016 2504017 2504018 2504021 2504022 2504025 2504026 2504029 2504030 2504031 2504032 2504035 2504036 2504038 2504039 2504040 2504044 2504047 2504049 2504050 2504051 2504054…
FDA’s list runs to 2,511 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 - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA, MA, TX, OH, NY, NC, IA, WA, TN, NJ, MO, LA, MN, AZ, VA, SC, KY, FL, MD, IN, AK, WI, NM, DC, RI, CT, CO, OK, DE, NE, MD, IL, NH and the countries of Germany, Canada.
The states and territories these words name
35 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
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.
The words say it went outside the United States too.
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 Oct 13, 2025.
- FDA classified it on Feb 20, 2026.
- FDA’s Enforcement Report published it on Mar 4, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MRIMed Inc., of Petaluma, 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 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 2,511 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
-
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.