REGARD Vitrectomy Tray Recalled for Out-of-Specification Antiseptic Component
ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because the povidone-iodine swab component was manufactured out of specifications. Distribution was limited to 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 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: This is an FDA Class II recall with no reported illnesses or injuries. The out-of-specification component presents a theoretical risk without documented harm, consistent with a moderate-severity precautionary recall.
Plain-English summary
ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because they contain a povidone-iodine swabstick component manufactured by PDI, Inc. that does not meet product specifications. The affected trays were distributed in Florida, Louisiana, and Missouri. Lot numbers 89042C and 85120B are affected.
Healthcare providers and facilities that received the recalled trays should discontinue use and contact ROi CPS LLC for instructions on returning or replacing the affected products.
The recalled product
- Product
- REGARD Vitrectomy Tray
- Manufacturer
- ROi CPS LLC
- Affected units
- 22
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 (1)
- Lots numbers: 89042C and 85120B
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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