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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 32 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-15U2-SFSMC4	FDA UDI	Class I	Active
Ohio	HS-04UC-F4F4C4	FDA UDI	Class I	Active
Ohio	HS-04UV-DFOFN4	FDA UDI	Class I	Active
Ohio	HS-12UO-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-08UC-DFDCC4	FDA UDI	Class I	Active
Ohio	HS-15UV-CMCFC5	FDA UDI	Class I	Active
Ohio	HS-14UO-CFDFN4	FDA UDI	Class I	Active
Ohio	HS-10UW-DFDHN5	FDA UDI	Class I	Active
Ohio	HS-08UN-DCSMC4	FDA UDI	Class I	Active
Ohio Medical Vacuum Regulator	PINA	FDA UDI	Class II	Active
Ohio	HS-26UO-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-12UW-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-04UN-DFDHC4	FDA UDI	Class I	Active
Ohio	HS-20UO-DFDFD4	FDA UDI	Class I	Active
Ohio	HS-10UV-DCM4C4	FDA UDI	Class I	Active
Ohio	HS-08UC-F4F4N4	FDA UDI	Class I	Active
Ohio	HS-15UO-SFSMC4	FDA UDI	Class I	Active
Ohio	HS-15UN-DADFC4	FDA UDI	Class I	Active
Ohio	HS-12UA-DFM4C4	FDA UDI	Class I	Active
Ohio	HS-01UN-F4XXC4	FDA UDI	Class I	Active
Ohio	HS-12UO-OFCMC4	FDA UDI	Class I	Active
Ohio	HS-03UV-DHPMC5	FDA UDI	Class I	Active
Ohio	HS-16UN-DHDCC4	FDA UDI	Class I	Active
Ohio	HS-15UA-DFDHC4	FDA UDI	Class I	Active
Ohio	HS-10UV-OFOMC5	FDA UDI	Class I	Active
Ohio	HS-13UN-DFSFC4	FDA UDI	Class I	Active
Ohio	HS-CS-MA-02060	FDA UDI	Class I	Active
Ohio	HS-01UW-CFDCC4	FDA UDI	Class I	Active
Ohio	HS-16UW-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-20UO-DFOMN4	FDA UDI	Class I	Active
Ohio	HS-14UW-DFCMC5	FDA UDI	Class I	Active
Ohio	HS-15U2-SFCMC4	FDA UDI	Class I	Active
Ohio	HS-12UO-DHOMC4	FDA UDI	Class I	Active
Ohio	HS-01UV-DFDMC5	FDA UDI	Class I	Active
Ohio	HS-40UV-MFMMC4	FDA UDI	Class I	Active
Ohio	HS-25UC-DFOFC4	FDA UDI	Class I	Active
Ohio	HS-15UW-F4F4C4	FDA UDI	Class I	Active
Flowmeter, Dial	FM-D-25IA	FDA UDI	Class I	Active
Ohio	HS-12UW-DHDHN5	FDA UDI	Class I	Active
Amvex Vacuum Regulator	N2P	FDA UDI	Class II	Active
Ohio	HS-25UA-DHOMC4	FDA UDI	Class I	Active
Ohio	HS-35UV-DFOMC5	FDA UDI	Class I	Active
Ohio	HS-16UN-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-10UW-OFOMC4M	FDA UDI	Class I	Active
Ohio	HS-12UW-DFOMN5	FDA UDI	Class I	Active
Ohio	HS-10UW-OMXXN5	FDA UDI	Class I	Active
Ohio	HS-30UA-DHOMC4	FDA UDI	Class I	Active
Ohio	HS-11UW-DFDFC5	FDA UDI	Class I	Active
Ohio	HS-17UO-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-36UO-DFOFN4	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.