Severity
Critical
FDA Devices recall · Reported February 20, 2013
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Ge Healthcare, LLC recalled Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [… - a critical-severity action.
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [… was recalled by Ge Healthcare, LLC in February 20, 2013. Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assemb…. Check the official notice for the remedy. Verify recall #Z-0749-2013 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this critical-severity FDA Devices recall-Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assemb….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0749-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0749-2013) was formally reported on February 20, 2013, with the manufacturer initiating the action on October 15, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 276 units total, 109 of those nationwide..
The documented reason for this recall is: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. Distribution data in the federal record shows the product reached: Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Austra…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
276 units total, 109 of those nationwide.
Related Recalls
6
3 from same agency
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0749-2013 |
| Date reported | February 20, 2013 |
| Date initiated | October 15, 2012 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 276 units total, 109 of those nationwide. |
| Distribution | Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
· 2026-07-02
· 2026-06-25
· 2026-06-18
GE Medical Systems Information Technologies Inc · 2026-06-03
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.