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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 3 of 140

Device	Model / Reference	Registries	Class	Status
Ohio	HS-CS-HP-02000	FDA UDI	Class I	Active
Ohio	HS-20UO-M4XXC4	FDA UDI	Class I	Active
Ohio	HS-01IA-DFDHC4	FDA UDI	Class I	Active
Ohio	HS-03UW-DFOFN5	FDA UDI	Class I	Active
Ohio	HS-04UV-M2CMC4	FDA UDI	Class I	Active
Ohio	HS-01UV-DHCFC5	FDA UDI	Class I	Active
Amvex Vacuum Regulator	LLL	FDA UDI	Class II	Active
Amvex Vacuum Regulator	C2P	FDA UDI	Class II	Active
Ohio	HS-16UV-DHXXC5	FDA UDI	Class I	Active
Ohio	HS-17UA-DFPMC4	FDA UDI	Class I	Active
Ohio	GR-CS-CF-00003	FDA UDI	Class I	Active
Ohio	HS-12UW-DHXXC4	FDA UDI	Class I	Active
Ohio	HS-01UO-ZFDMC4	FDA UDI	Class I	Active
Ohio	HS-12UV-OMXXC4M	FDA UDI	Class I	Active
Ohio	HS-15UV-DMOMC4	FDA UDI	Class I	Active
Ohio	HS-30U2-DFOFN4	FDA UDI	Class I	Active
Ohio	HS-10UO-DADFC4	FDA UDI	Class I	Active
Ohio	HS-25UW-DHCMC5	FDA UDI	Class I	Active
Ohio	HS-12UV-DFDMC5	FDA UDI	Class I	Active
Ohio	HS-10UA-DFOMD4	FDA UDI	Class I	Active
Ohio	HS-10U2-DHDHD4	FDA UDI	Class I	Active
Ohio	HS-04UO-F2F4C4	FDA UDI	Class I	Active
Ohio	HS-01UV-DMYMN4	FDA UDI	Class I	Active
Ohio	HS-14UA-DHDHC4	FDA UDI	Class I	Active
Ohio	HS-06U2-DFM2C4	FDA UDI	Class I	Active
Ohio	HS-08UI-DFM4C4	FDA UDI	Class I	Active
Ohio	HS-04UC-CFCMC4	FDA UDI	Class I	Active
Ohio	HS-26UO-DFDFC4B	FDA UDI	Class I	Active
Ohio	HS-12UC-CMDCN4	FDA UDI	Class I	Active
Ohio	HS-10UO-CFOMC4	FDA UDI	Class I	Active
Ohio	HS-99UO-DFDFN4	FDA UDI	Class I	Active
Ohio	HS-CS-DR-02006	FDA UDI	Class I	Active
Ohio	HS-03UV-OMXXC5	FDA UDI	Class I	Active
Ohio	GR-870-E9	FDA UDI	Class I	Active
Ohio	HS-13U2-NFBMC4	FDA UDI	Class I	Active
Ohio	HS-25UW-DFOMC4	FDA UDI	Class I	Active
Ohio	HS-16UN-DFDMC4	FDA UDI	Class I	Active
Ohio	HS-10UV-F4PMC5	FDA UDI	Class I	Active
Ohio	HS-10UV-CMXXC5	FDA UDI	Class I	Active
Ohio	HS-68UA-DHDHC4	FDA UDI	Class I	Active
Ohio	FI-T15UA-CN-A	FDA UDI	Class I	Active
Ohio	HS-14UN-SFSMC4	FDA UDI	Class I	Active
Ohio	HS-09UA-DHCMN4	FDA UDI	Class I	Active
Ohio	HS-03UO-DFMFC4	FDA UDI	Class I	Active
Ohio	HS-01UA-DFF4C4	FDA UDI	Class I	Active
Ohio	HS-10UA-DFF4C4	FDA UDI	Class I	Active
Ohio	HS-22UA-DFDCC4	FDA UDI	Class I	Active
Ohio	HS-08UN-DFSFC4	FDA UDI	Class I	Active
Ohio	HS-03U2-DMDMC4	FDA UDI	Class I	Active
Ohio	GR-BNO-BFXX-XXI	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.