Resource Optimization & Innovation Recalls 840 Sterile Surgical Extremity Packs
Resource Optimization & Innovation LLC is recalling 840 sterile surgical extremity packs because the equipment glove component may have splits or holes that compromise sterility.
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: The recall involves a risk-of-harm product (sterile surgical kit) where injury has not yet been reported, and the agency classification is Class II without explicit hospitalization reports in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 840 units of Item Number 800525, Sterile, OR0609 - Extremity Pack. These are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures. The affected lots are 17578, 18898, 20235, 21006, 21302, and 22981.
The recall was initiated because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical kit. The agency has classified this recall as Class II.
Distribution of the affected products was made to Louisiana, Mississippi, and Texas. The source text does not specify specific hospitals or facilities. Healthcare providers should stop using these kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 840
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 (6)
- Lot numbers 17578
- 18898
- 20235
- 21006
- 21302
- and 22981.
Distribution
Part of a larger recall action
This product is one of 77 recalled by Resource Optimization & Innovation 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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