Agency classClass IIOur severity:High FDA (Devices)·Z-1657-2017·Announced 2017-04-05

FDA Recalls 216 Spohn Laparoscopy Kits Due to Sterile Field Breach Risk

Resource Optimization & Innovation LLC is recalling 216 Spohn laparoscopy 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 216 kits of the Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn. 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. This failure can break the sterile field, which is a critical safety requirement for surgical procedures. The agency has classified this recall as Class II.

The affected products were distributed in the United States to locations in Louisiana and Texas. The recall covers specific lots with expiration dates ranging from July 16, 2017, to May 20, 2018. Healthcare facilities should stop using these kits and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
infection-risk
Affected units: 216

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 (6)

026440A Exp Date 2017-07-16
030021A Exp Date 2017-12-11
030186A Exp Date 2017-12-21
031464A Exp Date 2018-02-15
032390A Exp Date 2018-03-22
033782A Exp Date 2018-05-20

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