Is this your brand? Sign in to claim ownership.

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 108 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-32UV-DHOMN4	FDA UDI	Class I	Active
Ohio	HS-20UW-DHOMC4M	FDA UDI	Class I	Active
Ohio	HS-20UO-DHCMN4	FDA UDI	Class I	Active
Ohio	HS-01UW-DFDMC5	FDA UDI	Class I	Active
Ohio	HS-26U2-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-28UW-DHCMN5	FDA UDI	Class I	Active
Ohio	HS-40UV-CFCMC5	FDA UDI	Class I	Active
Ohio	HS-20UV-DHCMC4	FDA UDI	Class I	Active
Ohio	HS-16UW-OFOMC5	FDA UDI	Class I	Active
Ohio	HS-25UO-CMDCC4	FDA UDI	Class I	Active
Ohio	GR-870-FM15-PTI	FDA UDI	Class I	Active
Ohio	HS-30UO-OFXXC4	FDA UDI	Class I	Active
Ohio	HS-20UW-DFXXC5	FDA UDI	Class I	Active
Ohio	HS-10UV-DHOMC5	FDA UDI	Class I	Active
Ohio	HS-19UW-DFDFN5	FDA UDI	Class I	Active
Ohio	HS-19UI-DFM4C4	FDA UDI	Class I	Active
Ohio	HS-15UO-SFPMC4	FDA UDI	Class I	Active
Ohio	HS-14UA-HECMC4	FDA UDI	Class I	Active
Ohio	HS-08UN-DHXXC4	FDA UDI	Class I	Active
Ohio	HS-15UA-OFOMN4	FDA UDI	Class I	Active
Ohio	HS-08UA-DHDHN4M	FDA UDI	Class I	Active
Ohio	HS-30UW-DHDCC4	FDA UDI	Class I	Active
Ohio	HS-08UV-OFCMC5	FDA UDI	Class I	Active
Ohio	HS-15UV-DHSMC4	FDA UDI	Class I	Active
Ohio	HS-13UW-DHDCC5	FDA UDI	Class I	Active
Ohio	GR-346-DCXX-XXM	FDA UDI	Class I	Active
Ohio	HS-18UW-DFDFN5	FDA UDI	Class I	Active
Ohio	HS-03U2-OFPMC4	FDA UDI	Class I	Active
Ohio	HS-12UV-DFOFC4	FDA UDI	Class I	Active
Ohio	HS-18UW-DFF4C5	FDA UDI	Class I	Active
Ohio	HS-15UO-CMDMC4M	FDA UDI	Class I	Active
Ohio	HS-08UW-CFDFN5	FDA UDI	Class I	Active
Ohio	HS-08UN-DFXXC4	FDA UDI	Class I	Active
Ohio	HS-20U2-DHOMC4	FDA UDI	Class I	Active
Ohio	HS-50UV-DFCMC5	FDA UDI	Class I	Active
Ohio	HS-01U2-M4M4C4	FDA UDI	Class I	Active
Surgical Free Flow Vacuum Regulator	SCSA	FDA UDI	Class II	Unknown
Ohio	HS-40UO-DFDFC4	FDA UDI	Class I	Active
Ohio	HS-40UW-XXOMC4	FDA UDI	Class I	Active
Ohio	HS-12UV-DFDFC5	FDA UDI	Class I	Active
Ohio	HS-12UO-CMDCC4	FDA UDI	Class I	Active
Ohio	HS-CS-AT-02002	FDA UDI	Class I	Active
Ohio	HS-15UV-CMM2C4	FDA UDI	Class I	Active
Ohio	HS-50UA-DFCMN4	FDA UDI	Class I	Active
Ohio	HS-30UW-F2OMN5	FDA UDI	Class I	Active
Ohio	GR-F4A	FDA UDI	Class I	Active
Ohio	HS-01UN-M4F2C4	FDA UDI	Class I	Active
Ohio	HS-20UO-CMDMC4	FDA UDI	Class I	Active
Ohio	HS-30UO-CFCMC4M	FDA UDI	Class I	Active
Ohio	HS-15UO-DFOMC4M	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.