CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Giraffe Incubator Ohmeda Medical Giraffe Incubator recalled

Ohmeda Medical is recalling Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant, distributed nationwide in the US. The recall was initiated on 18 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSee Attached Spreadsheat

Quantity recalled5,993 (5,080 US; 913 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1505-2017
FDA event ID: 76283
Recalling firm: Ohmeda Medical, Laurel, MD
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2016
FDA classified: 20 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

18 Nov 2016	Recall initiated by company
20 Mar 2017	Classified by FDA	+122 days
29 Mar 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Where it was distributed

Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,

Nationwide Puerto Rico

Questions about this recall

Is Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant recalled?

Yes. Ohmeda Medical recalled Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant on 18 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-1505-2017.

Why was it recalled?

Which lots are affected?

See Attached Spreadsheat

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ohmeda Medical

All 13

Reported	Class	Recall	Company	Reason	Where
16 Oct 2019Device	CLASS II	Giraffe Omnibed recalled by Ohmeda Medical	Ohmeda Medical	Lead & Heavy Metals	Nationwide
4 Apr 2018Device	CLASS II	Rotating IV Pole Rotating IV Pole falls under the category recalled	Ohmeda Medical	Other	Nationwide
29 Mar 2017Device	CLASS II	Giraffe Exam Light The Exam Light illuminates body surfaces recalled	Ohmeda Medical	Other	Nationwide
29 Mar 2017Device	CLASS II	Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is recalled	Ohmeda Medical	Temperature Abuse	Nationwide
29 Mar 2017Device	CLASS II	IWS Infant Warmer System-Infant radiant warmers provide recalled	Ohmeda Medical	Temperature Abuse	Nationwide

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