FDA Recalls 146 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 146 sterile C-section surgical kits because equipment glove components 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterile surgical kit) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 146 sterile C-section surgical kits manufactured by Resource Optimization & Innovation LLC. The affected product is identified as Item Number 800508, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The recall is due to a defect where the equipment glove component may contain splits or holes, which compromises the sterility of the kits.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The specific lot numbers involved in this recall are 16153, 19010, 19989, 21287, and 21831. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected kits immediately. Users should contact the recalling firm, Resource Optimization & Innovation LLC, for instructions on how to return or dispose of the product.
The recalled product
- Product
- regard Item Number: 800508, Sterile, LD0586 - C Section - 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 surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 146
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 (5)
- Lot numbers 16153
- 19010
- 19989
- 21287
- and 21831.
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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