FDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance
Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting 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. The hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 17 units of Regard Custom Surgical Kits (Item Number 830500003, Sterile, CV0578C - CV PACK). These kits are used for surgery and were distributed in Texas and Louisiana.
The recall is being conducted because the kits contain a component, specifically ORS fluid warming and slush drapes, that was previously recalled. The package integrity of this component was compromised, which potentially affects the sterility assurance of the surgical kit.
Healthcare facilities that have received these kits should stop using them and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 17
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)
- 26550
Distribution
Part of a larger recall action
This product is one of 8 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 8 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
- HighFDA Recalls 658 Sterile Surgical Kits Due to Sterility Compromise
FDA (Devices) · 2015-10-14
- HighRegard Custom Surgical Pack Recalled Due to Chemical Contamination and Sterility Concerns
FDA (Devices) · 2015-09-30
- HighFDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
FDA (Devices) · 2015-10-14
- SevereRegard Custom Surgical Pack Recalled for Chemical Contamination and Sterility Issues
FDA (Devices) · 2015-09-30
- SevereFDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise
FDA (Devices) · 2015-10-14
- HighResource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-10-14