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Ohio Medical LLC

Last updated September 17, 2026

Information

Country: US
Address: 1111 LAKESIDE DR, Gurnee, IL, 60031
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1419185
DUNS Number: —

Catalogue (6983)

Page 135 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-32UA-DFOMC4	FDA UDI	Class I	Active
Ohio	HS-06UW-DHXXC5	FDA UDI	Class I	Active
Ohio	HS-20UV-DHPMC4	FDA UDI	Class I	Active
Ohio	HS-12UO-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-09UV-DFOFN4	FDA UDI	Class I	Active
Ohio	HS-40UA-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-20UA-M4M4C4	FDA UDI	Class I	Active
Ohio	HS-24UO-DFDHC4M	FDA UDI	Class I	Active
Ohio	HS-08UA-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-04U2-OFDMC4	FDA UDI	Class I	Active
Ohio	HS-12UC-DHDCC4	FDA UDI	Class I	Active
Ohio	HS-03UI-DFF4C4	FDA UDI	Class I	Active
Ohio	HS-20UA-DHCMN4	FDA UDI	Class I	Active
Ohio	HS-12UA-M2XXN4	FDA UDI	Class I	Active
Ohio	HS-10UA-DFOFN4	FDA UDI	Class I	Active
Ohio	HS-04UI-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-20UA-DHXXN4	FDA UDI	Class I	Active
Ohio	GR-CS-DR-00004	FDA UDI	Class I	Active
Ohio	HS-04UO-DHOFC4	FDA UDI	Class I	Active
Ohio	GR-870-DCXX-XXI	FDA UDI	Class I	Active
Legacy Flowmeter	FM-LT03IO	FDA UDI	Class I	Active
Ohio	HS-30U2-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-08U2-DHPMC4	FDA UDI	Class I	Active
Care-E-Vac 3	CARE-E-VAC 3	FDA UDI	Class II	Active
Ohio	HS-12UO-DHDMN4	FDA UDI	Class I	Active
Ohio	HS-12UA-CMDCN4	FDA UDI	Class I	Active
Ohio	HS-08UO-DFSFC4	FDA UDI	Class I	Active
Ohio	GR-870-FMN1-XXK	FDA UDI	Class I	Active
Ohio	HS-10U2-DFM2C4	FDA UDI	Class I	Active
Ohio	GR-870-DCXX-XXH	FDA UDI	Class I	Active
Ohio	HS-25UW-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-20UV-M2OMN4	FDA UDI	Class I	Active
Ohio	HS-16UA-CMXXC4	FDA UDI	Class I	Active
Ohio	HS-11UV-DFDHC5	FDA UDI	Class I	Active
Ohio	HS-15UV-F2OFC5	FDA UDI	Class I	Active
Ohio	HS-25UV-DHDEC5	FDA UDI	Class I	Active
Ohio	HS-06UN-M2M2C4	FDA UDI	Class I	Active
Ohio	FI-T08UO-ON-B	FDA UDI	Class I	Active
Ohio	HS-08UW-CMXXN5	FDA UDI	Class I	Active
Ohio	HS-12UV-DFF2C5	FDA UDI	Class I	Active
Ohio	HS-10UC-DFDHC4	FDA UDI	Class I	Active
Ohio	HS-25UV-DHCMC5	FDA UDI	Class I	Active
Ohio	HS-19UO-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-15UO-DHXMC4	FDA UDI	Class I	Active
Ohio	HS-10UO-DCPMC4	FDA UDI	Class I	Active
Ohio	HS-04UO-DHM4N4M	FDA UDI	Class I	Active
Ohio Medical Vacuum Regulator	PC2LD	FDA UDI	Class II	Active
Ohio	HS-23UH-DFDFG4	FDA UDI	Class I	Active
Ohio	HS-10UA-DFDFC4B	FDA UDI	Class I	Active
Ohio	HS-15U2-DFOMN4	FDA UDI	Class I	Active

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Authorities

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 8, 2025	Z-1980-2025	—	open, classified	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.
Nov 16, 2021	Z-0482-2022	—	open, classified	Increase in premature device failures
Aug 14, 2018	Z-2995-2018	—	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.
Mar 12, 2018	Z-2410-2018	—	terminated	Final quality control testing was not completed before the devices were distributed..
Nov 8, 2010	Z-0833-2011	—	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.
May 10, 2010	Z-1777-2010	—	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.
May 10, 2010	Z-1778-2010	—	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.
Sep 21, 2009	Z-0089-2010	—	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.
Sep 21, 2009	Z-0090-2010	—	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.