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Oto-Med, Inc.

Last updated May 27, 2026

Information

Device	Model / Reference	Registries	Class	Status
Glasscock Otology Surgery Drape	SD-2100	FDA UDI	Class II	Active
Glasscock Neurotology Surgery Drape	SD-2200	FDA UDI	Class II	Active
Glasscock® Ear Dressing, Pediatric	S-1003	FDA UDI	Class I	Unknown
Ear Dressing, Pediatric	S-1003	FDA UDI	Class I	Active
Sheehy Bone Dust Collector	S-2500	FDA UDI	Class I	Active
Glasscock® Ear Dressing, Adult	S-1000	FDA UDI	Class I	Unknown
Levine Irrigation-Suction Tubing	SP-3000	FDA UDI	Class I	Active
spineX BONE DUST COLLECTOR	S-4500	FDA UDI	Class II	Active
Ci Universal Drape	SD-2300	FDA UDI	Class II	Active
Ear Dressing, Adult	S-1000	FDA UDI	Class I	Active
Safetrap Tissue Collector	SP-2000	FDA UDI	Class II	Active
Cox Bone Dust Collector	S-3500	FDA UDI	Class I	Active
Sheehy-House Powder Insufflator	S-3001	FDA UDI	Class I	Active
Otomed® Suction Tubing	SP-4000	FDA UDI	Class I	Active
Head & Neck Pressure Dressing	S-1010-2	FDA UDI	Class I	Active
Levine Irrigation-Suction Kit	SP-3000	FDA UDI	Class I	Active

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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
Dec 7, 2020	Z-1520-2021	—	open, classified	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Dec 7, 2020	Z-1519-2021	—	open, classified	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Dec 7, 2020	Z-1521-2021	—	open, classified	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.