Drug & Device Safety Atlas

FDA recall record · openFDA

ROi CPS LLC

15 FDA recalls on record (2023–2024) — 15 device. 13 still ongoing.

3
Class I (most serious)
12
Class II
0
Class III
13
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fa 8
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received rel 1
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequent 1
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) 1
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pr 1

Recalls

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to Class I 2024-12-26 Regard Dressing change kit, Item Number 800026006 Class I 2023-11-20 regard Operative LAP, Item Number 800943001; surgical convenience kit Class I 2023-12-18 regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 Class II 2024-07-24 Regard Kit containing the Microtek decanter Class II 2024-06-17 Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. Class II 2023-03-22 GS0008 2Y - Burn Pack - STL, Item Number 880082025 Class II 2023-09-11 Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit Class II 2023-09-21 Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack. Class II 2023-03-22 Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath. Class II 2023-03-22 Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number Class II 2023-03-22 Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Class II 2023-03-22 Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regar Class II 2023-03-22 Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Class II 2023-03-22 Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack. Class II 2023-03-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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