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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 93 of 140

Device	Model / Reference	Registries	Class	Status
Amvex Vacuum Regulator	PPD	FDA UDI	Class II	Active
Ohio	HS-04UN-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-12UW-DHDHC5	FDA UDI	Class I	Active
Ohio	HS-10UA-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-18UO-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-46UA-F4DCC4	FDA UDI	Class I	Active
Ohio	HS-15UA-CMXXN4	FDA UDI	Class I	Active
Ohio	HS-20UA-PFDMC4	FDA UDI	Class I	Active
Ohio	HS-20U2-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-03UN-F2F2C4	FDA UDI	Class I	Active
Ohio	HS-10UV-CMDCC5	FDA UDI	Class I	Active
Ohio	HS-14UW-OFOMC5	FDA UDI	Class I	Active
Ohio	HS-04UV-CMM4C5	FDA UDI	Class I	Active
Ohio	HS-03UN-M2M2C4	FDA UDI	Class I	Active
Ohio	HS-27UA-DHOFC4	FDA UDI	Class I	Active
Ohio	HS-20U2-DHDCC4	FDA UDI	Class I	Active
Ohio	HS-20UA-SFCMC4	FDA UDI	Class I	Active
Ohio	HS-15UV-PFPMC5	FDA UDI	Class I	Active
Ohio	HS-10UO-DHF2N4	FDA UDI	Class I	Active
Ohio	HS-10UV-NFCMC5	FDA UDI	Class I	Active
Ohio	HS-20UA-CFCMC4	FDA UDI	Class I	Active
Ohio	HS-30UO-DHOMN4	FDA UDI	Class I	Active
Ohio	GR-950-E9XX-SFI	FDA UDI	Class I	Active
Ohio	HS-25UW-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-12UW-PMXXC4	FDA UDI	Class I	Active
Ohio	HS-12UI-DFM4C4	FDA UDI	Class I	Active
Ohio	HS-10U2-OFCMC4	FDA UDI	Class I	Active
Ohio	HS-12UO-M4OMN4	FDA UDI	Class I	Active
Ohio	HS-25UV-OMXXN4	FDA UDI	Class I	Active
Ohio	HS-04U2-DHDCN4	FDA UDI	Class I	Active
Ohio	HS-08UO-OMSMC4	FDA UDI	Class I	Active
Ohio	HS-01UW-F2M2N5	FDA UDI	Class I	Active
Ohio Medical Vacuum Regulator	PILA	FDA UDI	Class II	Active
Ohio	HS-17UW-CMM2C5	FDA UDI	Class I	Active
Ohio	HS-12U2-OFOMC4	FDA UDI	Class I	Active
Ohio	HS-12UN-DHSFN4	FDA UDI	Class I	Active
Ohio	HS-10UN-DHF4C4	FDA UDI	Class I	Active
Ohio	HS-20U2-DFNFC4	FDA UDI	Class I	Active
Ohio	HS-09UV-OMXXC4	FDA UDI	Class I	Active
Ohio	HS-25U2-F4CMC4	FDA UDI	Class I	Active
Ohio	HS-15U2-DHDHD4	FDA UDI	Class I	Active
Ohio	HS-06UI-DCM4G4	FDA UDI	Class I	Active
Ohio	HS-12UV-OFOMN4	FDA UDI	Class I	Active
Ohio	HS-20UN-DHM4C4	FDA UDI	Class I	Active
Ohio	HS-15UI-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-04UO-DFF4C4	FDA UDI	Class I	Active
Ohio	HS-03UA-OMOFN4	FDA UDI	Class I	Active
Ohio	FI-T15UA-CN-G	FDA UDI	Class I	Active
Ohio	HS-35UA-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-15UO-DFDHC4M	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.