Unomedical, Inc.
Country not established
- Devices
- 3
- FDA recalls
- 46
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 030271837
FDA recalls
2015
- 21 May 2015 Z-1821-2015 Class II Terminated Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Full distribution text
- 21 May 2015 Z-1821-2015 Class II Terminated Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
2014
- 7 Nov 2014 Z-0355-2017 Class II Terminated Tubing detachment
- 7 Nov 2014 Z-0356-2017 Class II Terminated Tubing detachment
- 7 Nov 2014 Z-0357-2017 Class II Terminated Tubing detachment
- 7 Nov 2014 Z-0358-2017 Class II Terminated Tubing detachment
- 7 Nov 2014 Z-0359-2017 Class II Terminated Tubing detachment
- 7 Nov 2014 Z-0360-2017 Class II Terminated Tubing detachment
2009
- 6 Oct 2009 Z-0039-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0040-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0041-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0039-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Show the 25 most recent of 46 recalls
2009
- 6 Oct 2009 Z-0042-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0043-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0044-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0045-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0046-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0047-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0048-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0049-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0050-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0051-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0052-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0053-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0054-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0055-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0056-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Full distribution text
- 6 Oct 2009 Z-0042-2010 Unclassified (pre-2012) Terminated In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Frequently asked questions
How many devices does UNOMEDICAL, INC. have in the registry?
The registry currently lists 3 devices for UNOMEDICAL, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list UNOMEDICAL, INC.'s devices?
Among its 3 most recently registered devices, UNOMEDICAL, INC. has devices listed in FDA GUDID (3 devices).
What risk classes do UNOMEDICAL, INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for UNOMEDICAL, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for UNOMEDICAL, INC.?
FDA recall records list 46 recalls initiated by UNOMEDICAL, INC., the most recent initiated on 21 May 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from UNOMEDICAL, INC. in the registry?
The most recently registered devices listed for UNOMEDICAL, INC. include Hospitak, Mouth to Mask Resuscitator with Filter Infant Mask 1055-E, Hospitak, Mouth to Mask Resuscitator with Filter Adult Large Mask 1059-E and Hospitak, Mouth to Mask Resuscitator with Filter Child Mask 1056-E.