CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report

Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical recalled

Resource Optimization & Innovation is recalling Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical, distributed in Louisiana, Texas. The recall was initiated on 9 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes037598B Exp Date: 2018-07-30;

Quantity recalled90 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1547-2017
FDA event ID: 76255
Recalling firm: Resource Optimization & Innovation, Springfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 9 Jan 2017
FDA classified: 24 Mar 2017
Reported: 5 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

9 Jan 2017	Recall initiated by company
24 Mar 2017	Classified by FDA	+74 days
5 Apr 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa

Where it was distributed

US Distribution to LA and TX.

Louisiana Texas

Questions about this recall

Is Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical recalled?

Yes. Resource Optimization & Innovation recalled Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical on 9 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1547-2017.

Why was it recalled?

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Which lots are affected?

037598B Exp Date: 2018-07-30;

Where was it sold?

US Distribution to LA and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Resource Optimization & Innovation

All 228

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022Device	CLASS II	Regard IV Start Kit for preparing and/or dressing recalled	Resource Optimization & Innovation	Other	MO
5 Aug 2020Device	CLASS II	regard Migrating Indicator, Steam Migrating Indicator Strips recalled	Resource Optimization & Innovation	Sterility	Nationwide
24 Jun 2020Device	CLASS II	Regard SRHS GIC Port A Cath, Sterile, Qty recalled	Resource Optimization & Innovation	Sterility	Nationwide
24 Jun 2020Device	CLASS II	Regard SRHS Central Line Kit, Sterile recalled	Resource Optimization & Innovation	Sterility	Nationwide
29 Nov 2017Device	CLASS II	Regard Custom Surgical Pack Packs contain surgical recalled	Resource Optimization & Innovation	Labeling Errors	TX

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