Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit — Class II medical device recall Z-0639-2016
Terminated recall by Mercury Enterprises, Inc. dba Mercury Medical, reported 2016-01-20, distributed nationwide. Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent
| Recall number | Z-0639-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mercury Enterprises, Inc. dba Mercury Medical, Clearwater, FL, United States |
| Recall initiated | 2015-10-22 |
| Classified | 2016-01-12 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2017-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BH, CA, CH, CL, CN, CO, DE, DK, EC, EG, ES, FI, FR, GB, HK, HU, IE, IL, IN, IR, IT, JP, KW, LB, LT, LV, MY, NL, NO, PL, PT, QA, SA, SE, SG |
| Quantity | 753,245 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10641043508015, 10641043508022, 10641043508039, 10641043508046, 10641043508053, 10641043508060, 10641043508077, 10641043508084, 10641043508091, 10641043508107, 10641043508114, 10641043508121, 10641043508152, 10641043508169, 10641043508176, 10641043508183, 10641043508190, 10641043508206, 10641043508213, 10641043508220, 10641043508237, 10641043508244, 10641043508251, 10641043508268, 10641043508275 and 3 more |
| Model numbers | 1050800, 1050801, 1050802, 1050803, 1050804, 1050805, 1050806, 1050807, 1050808, 1050809, 1050810, 1050811, 1050812, 10508138, 1050814, 1050815, 1050816, 1050817, 1050818, 1050819, 1050820, 1050821, 1050822, 1050823, 1050824 and 13 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0639-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.