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Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitat...

FDA Device Recall #Z-0639-2016 — Class II — October 22, 2015

Recall Summary

Recall Number Z-0639-2016
Classification Class II — Moderate risk
Date Initiated October 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mercury Enterprises, Inc. dba Mercury Medical
Location Clearwater, FL
Product Type Devices
Quantity 753,245 devices

Product Description

Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

Reason for Recall

Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirate, and United Kingdom..

Lot / Code Information

Neo-Tee Resuscitator: Part # 1050800 Unique Device ID # 10641043508004 Lot #s less than 1528850800; Part # 1050801 Unique Device ID # 10641043508015 Lot #s less than 1528850801;Part # 1050802 Unique Device ID # 10641043508022 Lot #s less than 1528850802; Part # 1050803 Unique Device ID # 10641043508039 Lot #s less than 1528850803; Part # 1050804 Unique Device ID # 10641043508046 Lot #s less than 1528850804; Part # 1050805 Unique Device ID # 10641043508053 Lot #s less than 1528850805; Part # 1050806 Unique Device ID # 10641043508060 Lot #s less than 1528850806; Part # 1050807 Unique Device ID # 10641043508077 Lot #s less than 1528850807; Part # 1050808 Unique Device ID # 10641043508084 Lot #s less than 1528850808; Part # 1050809 Unique Device ID # 10641043508091 Lot #s less than 1528850809; Part # 1050810 Unique Device ID # 10641043508107 Lot #s less than 1528850810; Part # 1050811 Unique Device ID # 10641043508114 Lot #s less than 1528850811; Part # 1050812 Unique Device ID # 10641043508121 Lot #s less than 1528850813; Part # 10508138 Unique Device ID # 10641043508004 Lot #s less than 1528850813; Part # 1050814 Unique Device ID # 106410435081454 Lot #s less than 1528850814; Part # 1050815 Unique Device ID # 10641043508152 Lot #s less than 1528850815; Part # 1050816 Unique Device ID # 10641043508169 Lot #s less than 1528850816; Part # 1050817 Unique Device ID # 10641043508176 Lot #s less than 1528850817; Part # 1050818 Unique Device ID # 10641043508183 Lot #s less than 1528850818; Part # 1050819 Unique Device ID # 10641043508190 Lot #s less than 1528850819; Part # 1050820 Unique Device ID # 10641043508206 Lot #s less than 1528850820; Part # 1050821 Unique Device ID # 10641043508213 Lot #s less than 1528850821; Part # 1050822 Unique Device ID # 10641043508220 Lot #s less than 1528850822; Part # 1050823 Unique Device ID # 10641043508237 Lot #s less than 1528850823; Part # 1050824 Unique Device ID # 10641043508244 Lot #s less than 1528850824; Part # 1050825 Unique Device ID # 10641043508251 Lot #s less than 1528850825; Part # 1050826 Unique Device ID # 10641043508268 Lot #s less than 1528850826; Part # 1050827 Unique Device ID # 10641043508275 Lot #s less than 1528850827; Part # 1050828 Unique Device ID # 10641043508282 Lot #s less than 1528850828; Part # 1050829 Unique Device ID # 10641043508299 Lot #s less than 1528850829; and Part # 1050830 Unique Device ID # 10641043508305 Lot #s less than 1528850830. T-Piece Resucitator Circuit Part # 1050900 Lot #s less than 1528850900, Part # 1050901 Lot #s less than 1528850901, Part # 1050902 Lot #s less than 1528850902, Part # 1050903 Lot #s less than 1528850903, Part # 1050904 Lot #s less than 1528850904, Part # 1050905 Lot #s less than 1528850905, and Part # 1050914 Lot #s less than 1528850914. T-Piece Neonatal Circuit Kit - Disposable M1091316VS Lot #s less than 15272, M1091335VS Lot #s less than 15272, and M1091365VS Lot #s less than 15272.

Other Recalls from Mercury Enterprises, Inc. dba Mercury...

Recall # Classification Product Date
Z-0821-2025 Class I Neo-Tee T-Piece Resuscitator, for pediatric eme... Dec 10, 2024
Z-0004-2025 Class I Neo-Tee T-Piece Resuscitator. Part Numbers 1050... Aug 30, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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