Regard Custom Surgical Pack Recalled Due to Chemical Contamination and Sterility Concerns
Resource Optimization & Innovation Llc is recalling 24 Regard Custom Surgical Packs because they may contain chemically contaminated scrub products and lack sterility assurance.
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 medical device with a risk of harm (chemical contamination and lack of sterility) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 24 units of the Regard Custom Surgical Pack, Item Number 800628; Sterile, CV0805 - CABG B. These kits are used in cardiovascular surgical procedures. The recall is being conducted because the surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
The affected products were distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC. The specific code information for the recalled items is 023735.
Consumers and healthcare facilities should stop using the affected surgical kits immediately. Users should contact Resource Optimization & Innovation Llc for instructions on how to return the products or obtain a replacement.
The recalled product
- Product
- Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
- 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)
- 023735
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 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 · chemical contamination
See all →- ModerateAVID Medical Recalls Plastic Trays Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Craniotomy Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Similar recalls
- SevereResource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls 28 Custom Cardiovascular Surgical Kits
FDA (Devices) · 2015-11-04
- HighFDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance
FDA (Devices) · 2015-11-04
- HighFDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighFDA Recalls Regard Custom Surgical Packs Due to Flow Restriction Issues
FDA (Devices) · 2015-11-11