CLASS II Device recall · Reported 14 Oct 2015 · FDA Enforcement Report

regard Item Number 800568001, Sterile, OR0658A - Titanium Rib recalled

Resource Optimization & Innovation is recalling regard Item Number 800568001, Sterile, OR0658A - Titanium Rib, distributed in Louisiana, Mississippi, Texas. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 24486.

Quantity recalled62 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-0102-2016
FDA event ID: 71904
Recalling firm: Resource Optimization & Innovation, Springfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 7 Oct 2015
Reported: 14 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

22 Apr 2015	Recall initiated by company
7 Oct 2015	Classified by FDA	+168 days
14 Oct 2015	Published in enforcement report	+7 days

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

Reason for recall

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

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 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Where it was distributed

Distribution was made to LA, MS, and TX.

Louisiana Mississippi Texas

Questions about this recall

Why was it recalled?

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Which lots are affected?

Lot number 24486.

Where was it sold?

Distribution was made to LA, MS, 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

76 other products · FDA event 71904

This product is part of a recall event; the main page for the event is regard Item Number: 800524001, Sterile, LD0608A - C Section recalled.

Reported	Class	Recall	Company	Reason	Where
14 Oct 2015	CLASS II	regard Item Number: 800524001, Sterile, LD0608A - C Section recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880323, Sterile, LD0754 - C Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800535, Sterile, LD0620 - C Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800036002, Sterile, LD0274B - C Section Pack recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800411, Sterile, NU0480 - Neuro Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800597, Sterile, GY0688 - Lavh - surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800566, Sterile, NU0655 - VP Shunt recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800531, Sterile, NU0615 - Neuro Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800514, Sterile, LD0592 - C Section Pack recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800091001, Sterile, LD0692A - C Section recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800568, Sterile, OR0658 - Titanium Rib recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800617, Sterile, NU0768 - Neuro Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800526, Sterile, ET0610 - Head and Neck recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800508, Sterile, LD0586 - C Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800524, Sterile, LD0608 - C Section - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800036003, Sterile, LD0274C - C Section Pack recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800560001, Sterile, GS0649A - Lap Chole recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800525, Sterile, OR0609 - Extremity Pack recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number 800567001, Sterile, GY0656A recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX
14 Oct 2015	CLASS II	regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk recalled	Resource Optimization & Innovation	Sterility	LA, MS, TX

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	Device Malfunction	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

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide