Recall of Regard Sterile Vaginal Kits Due to Glove Splitting Hazard
Resource Optimization & Innovation LLC is recalling 148 sterile vaginal kits because a light glove component may split, breaking the sterile field.
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 sterile medical device where a defect breaks the sterile field, creating a risk of harm (infection/contamination) even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 148 kits of Regard sterile vaginal kits (Item Number: 800418002). The recall is due to a defect in a light glove component included in the custom procedure trays.
The light glove can split during application to a light handle, which breaks the sterile field. This defect poses a risk of contamination during medical procedures. The affected products were distributed in the United States to locations in Louisiana and Texas.
The affected lots have expiration dates of November 4, 2017, December 29, 2017, February 3, 2018, and June 30, 2017. Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 148
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 (4)
- 029296B Exp Date 2017-11-04
- 030567B Exp Date 2017-12-29
- 031350B Exp Date 2018-02-03
- 033935B Exp Date 2017-06-30
Distribution
Part of a larger recall action
This product is one of 135 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 135 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 · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
FDA (Devices) · 2015-10-14
- 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 Risk
FDA (Devices) · 2015-10-14
- HighResource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-10-14
- HighResource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
FDA (Devices) · 2015-10-14
- SevereResource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits
FDA (Devices) · 2015-10-14