# FDA recall Z-0737-2021

> **ROi CPS LLC** · Class II · device recall initiated 2020-11-09.

## Product

Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges.    1)	Regard, PACEMAKER, Item 800221010, Lot # 82466.  2)	Regard, BASIC, Item 800109003 Lot # 83411.  3)	Regard, MAJOR EAR, Item 800070009, Lot # 82442.   4)	Regard, NEURO, Item 800040011, Lot # 82504.   5)	Regard, LAP CHOLE, Item 800003011, Lot # 82497.   6)	Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490.   7)	Regard, CERVICAL, Item 800058007, Lot # 82592.   8)	Regard, ARTHROSCOPY, Item 800027008, Lot # 82582.   9)	Regard, MAJOR SURGERY, Item 800013010, Lot # 82844.   10)	Regard, GENERAL SURGERY, Item 800057012, Lot # 82832.  11)	Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876.   12)	Regard, MINOR 	FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893.   13)	Regard, KNEE ARTHRO, Item 800072009, Lot # 83058.   14)	Regard, LAP, Item 800096005, Lot # 83139.   15)	Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251.   16)	Regard, CYSTOSCOPY, Item 800093007, Lot # 83138.   17)	Regard, LAP CHOLE, Item 80003500

## Reason for recall

Gauze sponges contained in custom kits may be flaking or fraying.

## Distribution

US Domestic Distribution Only: MO, NC, LA and FL.

## Key facts

- **Recall number:** Z-0737-2021
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-09
- **Report date:** 2021-01-06
- **Termination date:** 2021-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Republic, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0737-2021

## Citation

> AI Analytics. FDA recall Z-0737-2021. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-0737-2021. Source: US FDA. Licensed CC0.

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