Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterility compromise in surgical kits, which poses a significant risk of infection or injury during surgery, meeting the criteria for a Severe rating.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 24 sterile pediatric heart surgical kits (Item Number 800565, CV0654) manufactured in St. Louis, MO. The recall affects kits with lot numbers 17478 and 18149.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes, which could compromise the sterility of the surgical instruments and accessories. These custom procedure trays are intended for use during surgical procedures.
Distribution of the affected kits was made to Louisiana, Mississippi, and Texas. The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - 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
- 24
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)
- Lot numbers 17478 and 18149
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.
See all 77 products in this recall →Related recalls
Same manufacturer · Resource Optimization & Innovation Llc
See all →- HighFDA recalls Regard IV Start Kit component over safety issue
FDA (Devices) · 2022-04-27
- ModerateResource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
FDA (Devices) · 2020-08-05
- HighResource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard Custom Surgical Packs Due to Label Error
FDA (Devices) · 2017-11-29
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighResource Optimization Recalls 28 Custom Cardiovascular Surgical Kits
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- SevereFDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighFDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- SevereResource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighRecall of Regard Sterile Open Heart Procedure Kits Due to Glove Defect
FDA (Devices) · 2017-04-05