Oto Med Recalls Bone Dust Collectors Due to Sterile Pouch Defects
Oto Med Inc is recalling 5,092 Grace Medical Cox Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a packaging integrity issue (holes in sterile pouches) discovered during internal testing with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oto Med Inc is recalling 5,092 units of the Grace Medical REF S-3500 Cox Bone Dust Collector. These medical devices are intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
The recall was initiated after holes were discovered in the sterile Tyvek pouches of the devices during internal Age Testing. The affected devices were distributed worldwide, including nationwide in the United States and in various international locations such as Canada, India, and several countries in South America, Asia, and Africa.
Healthcare providers and facilities should stop using the affected devices and contact Oto Med Inc for further instructions. Consumers are advised to check their inventory for the specific lot numbers listed in the recall notice.
The recalled product
- Product
- Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
- Manufacturer
- Oto Med Inc
- Affected units
- 5,092
Distribution
Part of a larger recall action
This product is one of 3 recalled by Oto Med Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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