Oto Med Recalls Sheehy Bone Dust Collectors Due to Packaging Defects
Oto Med Inc is recalling 13,335 Sheehy Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.
What this means for you
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging defect (holes in sterile pouches) which is a theoretical risk of contamination rather than a confirmed adverse event, fitting the criteria for a moderate severity score.
Plain-English summary
Oto Med Inc is recalling 13,335 units of the Grace Medical REF S-2500 Sheehy Bone Dust Collector. These stainless steel filters 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 because holes were found in the sterile Tyvek pouches of the devices during internal Age Testing. This defect compromises the sterile barrier of the packaging.
The affected devices were distributed worldwide, including nationwide in the United States and in various international locations. The specific lot numbers involved are 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), and 200401. The UDI Code is 00850000126046. Healthcare providers should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - 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
- 13,335
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.
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