Ohio Medical LLC
United Statesfrom the FDA registration address FDA establishment FEI 1419185
- Devices
- 12,161
- Registrations
- FDA
- FDA recalls
- 92 ongoing
What Ohio Medical LLC makes
Ohio Medical LLC manufactures reusable general-gas low pressure tubing, non-fixed medical gas cylinder regulators, vacuum suction regulators and regulation sets for general-purpose use, Thorpe tube medical gas flowmeters, oxygen and carbon dioxide low pressure hoses, and reusable surgical suction system collection containers, along with vacuum hoses.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) registry. Ohio Medical LLC is based in the United States.
Catalogue
Search and filter all 12,161 devicesShowing 1-50 of 12,161
Company details
- FDA FEI number
- 1419185
- Address
- 1111 LAKESIDE DR, Gurnee, IL, 60031
FDA recalls
FDA recall records list 9 recalls initiated by Ohio Medical LLC, the earliest on 2009-09-21 and the most recent on 2025-05-08. By recorded status: 2 ongoing and 7 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 8 May 2025 Z-1980-2025 Class II Ongoing Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
2021
- 16 Nov 2021 Z-0482-2022 Class II Ongoing Increase in premature device failures
2018
- 14 Aug 2018 Z-2995-2018 Class II Terminated The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
- 12 Mar 2018 Z-2410-2018 Class II Terminated Final quality control testing was not completed before the devices were distributed..
2010
- 8 Nov 2010 Z-0833-2011 Unclassified (pre-2012) Terminated The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
Full distribution text
- 10 May 2010 Z-1777-2010 Unclassified (pre-2012) Terminated Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
- 10 May 2010 Z-1778-2010 Unclassified (pre-2012) Terminated Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.
- 8 Nov 2010 Z-0833-2011 Unclassified (pre-2012) Terminated The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
2009
- 21 Sep 2009 Z-0089-2010 Unclassified (pre-2012) Terminated The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
Full distribution text
- 21 Sep 2009 Z-0090-2010 Unclassified (pre-2012) Terminated The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
Full distribution text
- 21 Sep 2009 Z-0089-2010 Unclassified (pre-2012) Terminated The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
Frequently asked questions
How many devices does Ohio Medical LLC have in the registry?
The registry currently lists 12161 devices for Ohio Medical LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ohio Medical LLC's devices?
Among its 50 most recently registered devices, Ohio Medical LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Ohio Medical LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ohio Medical LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Ohio Medical LLC?
FDA recall records list 9 recalls initiated by Ohio Medical LLC, the most recent initiated on 8 May 2025. 2 of them are recorded as ongoing. 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 Ohio Medical LLC in the registry?
The most recently registered devices listed for Ohio Medical LLC include Ohio HS-50UW-DFDFC4, Ohio HS-50U2-DFDFC4, Ohio HS-20UW-F2F4N5 and Ohio HS-13UO-OFOMC4.