Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 6, 2021
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)
Gauze sponges contained in custom kits may be flaking or fraying.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
ROi Cps LLC recalled Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, P… - a moderate-severity action.
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, P… was recalled by ROi Cps LLC in January 6, 2021. Reason: Gauze sponges contained in custom kits may be flaking or fraying.. Check the official notice for the remedy. Verify recall #Z-0737-2021 with the FDA Devices before acting.
The recall
ROi Cps LLC issued this moderate-severity FDA Devices recall-Gauze sponges contained in custom kits may be flaking or fraying..
- Moderate
- severity level
- Class II
- classification
- January 6, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0737-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0737-2021) was formally reported on January 6, 2021, with the manufacturer initiating the action on November 9, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. ROi Cps LLC is listed as the recalling firm, operating out of Republic, MO. Federal records list the affected scope as 17,700 total kits.
The documented reason for this recall is: Gauze sponges contained in custom kits may be flaking or fraying. Distribution data in the federal record shows the product reached: US Domestic Distribution Only: MO, NC, LA and FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
17,700 total kits
Related Recalls
6
3 from same agency
Product description
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 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88
Reason for recall
Gauze sponges contained in custom kits may be flaking or fraying.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0737-2021 |
| Date reported | January 6, 2021 |
| Date initiated | November 9, 2020 |
| Recalling firm | ROi Cps LLC |
| Firm location | Republic, MO |
| Affected scope | 17,700 total kits |
| Distribution | US Domestic Distribution Only: MO, NC, LA and FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0737-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88. Recalled by ROi Cps LLC. Units affected: 17,700 total kits.
Why was this product recalled? ▼
Gauze sponges contained in custom kits may be flaking or fraying.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2021. Severity: Moderate. Recall number: Z-0737-2021.
Where was the recalled product distributed? ▼
Distribution: US Domestic Distribution Only: MO, NC, LA and FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0737-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 6, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.