REGARD Ear Tray recalled due to out-of-spec swabstick component
ROi CPS LLC is recalling the REGARD Ear Tray because it contains a Povidone-Iodine swabstick component that does not meet specifications. The product was distributed in Florida, Louisiana, and Missouri.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for an out-of-specification component with no reported illnesses or injuries. A medical device with a quality defect where harm has not yet been reported meets the criteria for High severity.
Plain-English summary
The REGARD Ear Tray, manufactured by ROi CPS LLC, is being recalled. The product contains a Povidone-Iodine swabstick component manufactured by PDI, Inc. that was found to be out of specifications.
Forty-four trays were affected, distributed in Florida, Louisiana, and Missouri. The affected lot numbers are 88400C, 87798C, 86311C, and 88537C.
Consumers who possess the affected product should discontinue use and contact ROi CPS LLC or their healthcare provider for guidance.
The recalled product
- Product
- REGARD Ear Tray
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Ear Tray
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots numbers: 88400C
- 87798C
- 86311C and 88537C
Distribution
Part of a larger recall action
This product is one of 7 recalled by ROi CPS LLC 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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