Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 20, 2016
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
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Mercury Enterprises, Inc. dba Mercury Medical recalled Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Re… - a moderate-severity action.
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Re… was recalled by Mercury Enterprises, Inc. dba Mercury Medical in January 20, 2016. Reason: Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequen…. Check the official notice for the remedy. Verify recall #Z-0639-2016 with the FDA Devices before acting.
The recall
Mercury Enterprises, Inc. dba Mercury Medical issued this moderate-severity FDA Devices recall-Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequen….
- Moderate
- severity level
- 753K units
- affected scope
- Class II
- classification
- January 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0639-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0639-2016) was formally reported on January 20, 2016, with the manufacturer initiating the action on October 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Mercury Enterprises, Inc. dba Mercury Medical is listed as the recalling firm, operating out of Clearwater, FL. Federal records list the affected scope as 753,245 devices, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. Distribution data in the federal record shows the product reached: 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, Irel…. 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.
Medical Devices recalls over time
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
753,245 devices
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0639-2016 |
| Date reported | January 20, 2016 |
| Date initiated | October 22, 2015 |
| Recalling firm | Mercury Enterprises, Inc. dba Mercury Medical |
| Firm location | Clearwater, FL |
| Affected scope | 753,245 devices |
| Distribution | 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, … |
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.
- Check the recall number (Z-0639-2016) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
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. Recalled by Mercury Enterprises, Inc. dba Mercury Medical. Units affected: 753,245 devices.
Why was this product recalled? ▼
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0639-2016.
Where was the recalled product distributed? ▼
Distribution: 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...
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0639-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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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 January 20, 2016. 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.