ROi CPS recalls

ROi CPS has 86 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 12 Feb 2025. 14 are still ongoing.

Total recalls86since 2020

Last 12 months0reported

Class I33% of total

Ongoing14latest 12 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 1Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 3 3%Class II 82 95%Class III 1 1%

Why roi cps is recalled

Product types

By year

202511%
202445%
20231012%
20225260%
20211416%
202056%

Ongoing roi cps recalls

14 active

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS I	regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled	ROi CPS	Potency & Assay	MO
25 Sep 2024Device	CLASS II	regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled	ROi CPS	Packaging Defects	Nationwide
28 Aug 2024Device	CLASS II	Regard Kit containing the Microtek decanter recalled by ROi CPS	ROi CPS	Sterility	Nationwide
22 Nov 2023Device	CLASS II	Regard CV PK recalled by ROi CPS	ROi CPS	Other	MO
11 Oct 2023Device	CLASS II	GS0008 2Y - Burn Pack - STL recalled by ROi CPS	ROi CPS	Other	MO
3 May 2023Device	CLASS II	Sterile surgical convenience kit: regard recalled by ROi CPS	ROi CPS	Other	Nationwide

All roi cps recalls, newest first

86 total

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS I	regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled	ROi CPS	Potency & Assay	MO
25 Sep 2024Device	CLASS II	regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled	ROi CPS	Packaging Defects	Nationwide
28 Aug 2024Device	CLASS II	Regard Kit containing the Microtek decanter recalled by ROi CPS	ROi CPS	Sterility	Nationwide
24 Jan 2024Device	CLASS I	regard Operative LAP recalled by ROi CPS	ROi CPS	Other	LA
10 Jan 2024Device	CLASS I	Regard Dressing change kit recalled by ROi CPS	ROi CPS	Other	Nationwide
22 Nov 2023Device	CLASS II	Regard CV PK recalled by ROi CPS	ROi CPS	Other	MO
11 Oct 2023Device	CLASS II	GS0008 2Y - Burn Pack - STL recalled by ROi CPS	ROi CPS	Other	MO
3 May 2023Device	CLASS II	Sterile surgical convenience kit: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kits: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kits: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kits: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kits: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kit: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kit: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
3 May 2023Device	CLASS II	Sterile surgical convenience kit: regard recalled by ROi CPS	ROi CPS	Other	Nationwide
30 Nov 2022Device	CLASS II	¿regard Shoulder PK, GS00125U recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Spine Pack , NU00193N recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	¿regard EYE TRAY, EY00099AE recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Major Crani, NU00921E recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Vitrectomy Pack, EY00266H recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Laminectomy, NU01140 recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Spine , NU00974F recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Major EAR, ET00326J recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Neuro Tray, NU00160R recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Pediatric Urology, GS00467J recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Spine Pack,NU00395J recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Kyphoplasty, OR01101 recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Vitrectomy PK, EY00938C recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard Minor Davinci Pack, GS00349M recalled by ROi CPS	ROi CPS	Other	4 states
30 Nov 2022Device	CLASS II	regard ACDF, NU00698I recalled by ROi CPS	ROi CPS	Other	4 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.