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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 12 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	GR-870-FM08-SWL	FDA UDI	Class I	Active
Ohio	HS-04UV-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-15UC-DMDMC4	FDA UDI	Class I	Active
Ohio	HS-12UW-DHF4C4	FDA UDI	Class I	Active
Ohio	HS-10UO-DHPMC4	FDA UDI	Class I	Active
Ohio	HS-08UV-PMXXC5	FDA UDI	Class I	Active
Ohio	GR-870-YBXX-BFI	FDA UDI	Class I	Active
Ohio	HS-04UO-CFDFC4M	FDA UDI	Class I	Active
Ohio	HS-22UA-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-25UV-CMCMC4	FDA UDI	Class I	Active
Ohio	HS-15UV-DHDHD4	FDA UDI	Class I	Active
Ohio	HS-02UN-DHDNC4	FDA UDI	Class I	Active
Ohio	HS-15UV-DHOMC4M	FDA UDI	Class I	Active
Ohio	HS-15UO-OFPMC4	FDA UDI	Class I	Active
Ohio	HS-01UO-M4M4C4	FDA UDI	Class I	Active
Ohio	HS-08UV-DFCMC5	FDA UDI	Class I	Active
Ohio	HS-04UV-PMXXC4	FDA UDI	Class I	Active
Ohio	HS-15UW-DHCMN5	FDA UDI	Class I	Active
Ohio	HS-15UO-DFT4C4	FDA UDI	Class I	Active
Ohio	HS-12UW-DFDFN5	FDA UDI	Class I	Active
Ohio	HS-10UW-CFDFC4	FDA UDI	Class I	Active
Ohio	HS-15UN-DHHCC4	FDA UDI	Class I	Active
Ohio	HS-10UC-NFGMC4	FDA UDI	Class I	Active
Ohio	HS-19UI-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-08UW-DFOMC4	FDA UDI	Class I	Active
Ohio	GR-346-PF	FDA UDI	Class I	Active
Ohio	HS-10U2-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-06UV-DF6BC5	FDA UDI	Class I	Active
Ohio	HS-04UA-CFDHC4	FDA UDI	Class I	Active
Ohio	HS-16UV-DFXXC5	FDA UDI	Class I	Active
Ohio	HS-16U2-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-14UN-F4M4C4	FDA UDI	Class I	Active
Ohio	HS-10UO-NFCMD4	FDA UDI	Class I	Active
Ohio	HS-CS-MN-02007	FDA UDI	Class I	Active
Ohio	HS-03UW-MFPMC4	FDA UDI	Class I	Active
Ohio	HS-23UA-DFOFC4	FDA UDI	Class I	Active
Ohio	HS-12UV-DHOMC5	FDA UDI	Class I	Active
Ohio	HS-08UW-F2CMC5	FDA UDI	Class I	Active
Ohio	HS-45U2-DHCEC4	FDA UDI	Class I	Active
Ohio	HS-24UW-DFDHC5	FDA UDI	Class I	Active
Ohio	HS-13UO-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-18UV-DHXXC4	FDA UDI	Class I	Active
Ohio	HS-22UN-DFDCC4	FDA UDI	Class I	Active
Ohio	HS-15UW-CFCMC4	FDA UDI	Class I	Active
Ohio	HS-15UW-DHF4C4	FDA UDI	Class I	Active
Ohio	HS-10UO-DFM4C4	FDA UDI	Class I	Active
Ohio	HS-08UO-DHOMC4	FDA UDI	Class I	Active
Ohio	GR-950-FM15-PTI	FDA UDI	Class I	Active
Ohio	HS-CS-MS-02005	FDA UDI	Class I	Active
Ohio	HS-CS-MA-02030	FDA UDI	Class I	Active

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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.