CriticalClass ITerminated

FDA Devices recall · Reported February 20, 2013

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 20, 2013. Severity: Critical. Recall number: Z-0749-2013.

Q: Where was the recalled product distributed?

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, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Recall #: Z-0749-2013
Affected scope: 276 units total, 109 of those nationwide.
Initiated: October 15, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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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….

Critical
severity level: 276 units
affected scope: Class I
classification: February 20, 2013
reported

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.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

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.

Reason for recall

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Recall Profile

Structured summary of the FDA Devices recall record
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.

Scale of Impact

276 units total, 109 of those nationwide. units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0749-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

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.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 20, 2013. Severity: Critical. Recall number: Z-0749-2013.

Where was the recalled product distributed? ▼

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, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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This recall: FDA Devices, reported February 20, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026