Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates…
Medical device recall Z-1846-2019. Published in FDA’s Enforcement Report on Jul 17, 2019.
- 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 Jul 17, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 53 states named
- 9,094 devices 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?
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate’s transition to the external environment or to provide a controlled open environment.
9,094 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number, (Serial Number, UDI Number): M1118179-529707 (GBWW60444, 010084068210392321GBWW6044411170620); M1118179-529707 (GBWW60446, 010084068210392321GBWW6044611170620); M1118179-024201 (HDJM50619, Not Applicable); M1118179-024201…
Every code shown here, 1,993 characters
Model Number, (Serial Number, UDI Number): M1118179-529707 (GBWW60444, 010084068210392321GBWW6044411170620); M1118179-529707 (GBWW60446, 010084068210392321GBWW6044611170620); M1118179-024201 (HDJM50619, Not Applicable); M1118179-024201 (HDJM50620, Not Applicable); M1118179-025977 (HDJN50298, Not Applicable); M1118179-025977 (HDJN50299, Not Applicable); M1118179-029089 (HDJP50554, Not Applicable); M1118179-029089 (HDJP50555, Not Applicable); M1118179-038813 (HDJR54214, Not Applicable); M1118179-038813 (HDJR54215, Not Applicable); M1118179-038813 (HDJR54216, Not Applicable); M1118179-024011 (HDJS50551, Not Applicable); M1118179-024011 (HDJS50552, Not Applicable); M1118179-024011 (HDJS50553, Not Applicable); M1118179-024011 (HDJS50554, Not Applicable); M1118179-024011 (HDJS50555, Not Applicable); M1118179-150421 (HDJU61285, Not Applicable); M1118179-150421 (HDJU61286, Not Applicable); M1118179-150421 (HDJU61287, Not Applicable); M1118179-150421 (HDJS52930, Not Applicable); M1118179-150421 (HDJS52931, Not Applicable); M1118179-150421 (HDJS52933, Not Applicable); M1118179-150421 (HDJS55007, Not Applicable); M1118179-150421 (HDJS55009, Not Applicable); M1118179-496386 (HDJV61053, Not Applicable); M1118179-496386 (HDJV61054, Not Applicable); M1118179-526626 (GBWW60945, 010084068210392321GBWW6094611171207); M1118179-526626 (GBWW60946, 010084068210392321GBWW6094911171211); M1118179-526626 (GBWW60949, 010084068210389321PBWW6274611171120); M1118179-022806 (HDJM50505, Not Applicable); M1118179-022806 (HDJM50506, Not Applicable); M1118179-022806 (HDJM50507, Not Applicable); M1118179-022806 (HDJM50509, Not Applicable); M1118179-022806 (HDJM50510, Not Applicable); M1118179-022806 (HDJM50511, Not Applicable); M1118179-022806 (HDJM50512, Not Applicable); M1118179-022806 (HDJM50513, Not Applicable); M1118179-022806 (HDJM50514, Not Applicable); M1118179-022806 (HDJM50515, Not Applicable); M1118179-022806 (HDJM50517, Not Applicable); M1118179-022806 (HDJM50518, Not Applicable);…
FDA’s list runs to 475,746 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: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Guam, Northern Mariana Islands; and to countries of: Albania, Algeria, Argentina, Aruba, Australia, , Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Korea (Republic of), Kuwait, Lebanon, Libya, Lithuania, Macau, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, STATE OF, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
The states and territories these words name
53 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
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 Mar 15, 2019.
- FDA classified it on Jul 11, 2019.
- FDA’s Enforcement Report published it on Jul 17, 2019.
- FDA terminated it on May 21, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- 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 475,746 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.