Giraffe WarmerRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00840682103923), received between Apr 22, 2019 and Sep 28, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

20 other recalls cover devices cleared under the same FDA submission (K070377, K090697, K101804, K122267, K123309, K201628); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914360 ↗
• MalfunctionSep 23, 2026Mechanical Problem

  It was reported that there was a malfunction during pre-use checkout resulting in unavailable oxygen therapy. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867675 ↗
• MalfunctionSep 16, 2026Insufficient Flow or Under Infusion

  It was reported that there was a malfunction during pre-use checkout resulting in prolonged insufficient oxygen (O2) concentration. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786895 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292711 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THE UNIT HAD A BROKEN SIDE PANEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199036 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE FRONT PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521385 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390594 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975757 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494416 ↗
• MalfunctionJun 30, 2025Crack; Crack

  IT WAS REPORTED THAT THE SOUTH WALL WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363035 ↗
• MalfunctionMay 20, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051099 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039079 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985178 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883257 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756326 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719182 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THE SIDE PANEL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719176 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT THE UNIT HAD A BROKEN FRONT PANEL DOOR LATCH PIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080395 ↗
• MalfunctionDec 11, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902585 ↗
• MalfunctionNov 12, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIDE PANEL / WALL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668822 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT THE SOUTH WALL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095216 ↗
• MalfunctionAug 5, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED A BROKEN SIDE PANEL WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8861266 ↗
• MalfunctionJul 22, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED THE SIDE RAIL CLIP MALFUNCTIONED WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8812688 ↗
• MalfunctionJul 22, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED A BROKEN SIDE RAIL WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8812617 ↗
• MalfunctionMay 14, 2019Material Integrity Problem; Material Integrity Problem

  THE HOSPITAL REPORTED THAT THE CLEAR SIDE RAIL ON ONE SIDE IS COMPLETELY BROKEN WHICH COULD CAUSE A PATIENT FALL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8607490 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070377, K090697, K101804, K122267, K123309, K201628. One submission often covers many models, so check the product and lot details in each record.

• Z-2359-2026 · May 8, 2026 · Open, Classified
  Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenanc
• Z-2358-2026 · May 8, 2026 · Open, Classified
  Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if servi
• Z-3080-2024 · Aug 9, 2024 · Open, Classified
  GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based o
• Z-3081-2024 · Aug 9, 2024 · Open, Classified
  GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-010487
• Z-1846-2019 · Mar 15, 2019 · Terminated
  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. Infa
• Z-1847-2019 · Mar 15, 2019 · Terminated
  Panda 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
• Z-0482-2019 · Sep 25, 2018 · Terminated
  Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
• Z-0484-2019 · Sep 25, 2018 · Terminated
  Panda Wall Mount warmer. Infant radiant warmer
• Z-0481-2019 · Sep 25, 2018 · Terminated
  Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
• Z-0483-2019 · Sep 25, 2018 · Terminated
  Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
• Z-1506-2017 · Nov 18, 2016 · Terminated
  Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based
• Z-1508-2017 · Nov 18, 2016 · Terminated
  Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to therm
• Z-1547-2014 · Apr 2, 2014 · Terminated
  Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitorin
• Z-1550-2014 · Apr 2, 2014 · Terminated
  Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated
• Z-1548-2014 · Apr 2, 2014 · Terminated
  Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monito

…and 5 more.