Agency classClass IIOur severity:High FDA (Devices)·Z-1642-2017·Announced 2017-04-05

FDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk

Resource Optimization & Innovation LLC is recalling 230 sterile C-section procedure kits because a light glove component can 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 is classified as FDA Class II. The hazard involves breaking the sterile field during a surgical procedure, which poses a risk of harm (infection) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 230 sterile C-section procedure kits (Item Number: 800408003, Lot 034222S, Exp Date 2018-06-14) manufactured by Resource Optimization & Innovation LLC. The kits were distributed in California and Texas.

The recall is being conducted because the kits contain a light glove component that can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement in surgical procedures.

Healthcare facilities and consumers who possess these specific kits should stop using them immediately and contact the manufacturer for instructions on return or replacement. The FDA classifies this as a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
infection-risk
Affected units: 230

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)

034222S Exp Date 2018-06-14

Distribution

Distributed in 2 states:

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 →

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Same hazard · sterile field breach