Giraffe Incubator Carestation CS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00840682116855), received between Mar 14, 2024 and Sep 8, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “No Flow” (19 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K152809, K213553, K251663); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 6, 2023Class ICompleted

   Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

   Z-0141-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669235 ↗
• MalfunctionApr 28, 2026Inaccurate Delivery

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INCREASE THE PERCENTAGE OF OXYGEN DELIVERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018108 ↗
• MalfunctionApr 9, 2026No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829004 ↗
• MalfunctionMar 17, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN THERAPY DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618374 ↗
• MalfunctionMar 11, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569122 ↗
• MalfunctionMar 4, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY OXYGEN DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512190 ↗
• MalfunctionFeb 10, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309165 ↗
• MalfunctionJan 12, 2026Insufficient Flow or Under Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035849 ↗
• MalfunctionDec 26, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898922 ↗
• MalfunctionDec 26, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898589 ↗
• MalfunctionDec 26, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898577 ↗
• MalfunctionDec 26, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898576 ↗
• MalfunctionDec 26, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898575 ↗
• MalfunctionDec 16, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL TO LEAD TO A SIGNIFICANT DEGRADATION OR LOSS OF OXYGEN THERAPY DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822063 ↗
• MalfunctionNov 25, 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 23648597 ↗
• MalfunctionNov 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533712 ↗
• MalfunctionSep 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN THERAPY FAILURE DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063864 ↗
• MalfunctionSep 5, 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 22977416 ↗
• MalfunctionSep 4, 2025No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961966 ↗
• MalfunctionSep 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952632 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946446 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT THE HEATER DOOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22941980 ↗
• MalfunctionAug 25, 2025No Flow; No Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889886 ↗
• MalfunctionJul 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN SIGNIFICANT DEGRADATION OR LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473587 ↗
• MalfunctionJul 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152809, K213553, K251663. One submission often covers many models, so check the product and lot details in each record.

• Z-0540-2020 · Oct 11, 2019 · Terminated
  Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
• Z-0480-2019 · Sep 25, 2018 · Terminated
  Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1