CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
Custom procedure packs, containing banded Raytec 16ply gauze sponges recalled
ROi CPS is recalling Custom procedure packs, containing banded Raytec 16ply gauze sponges, distributed in Florida, Louisiana, Missouri, North Carolina. The recall was initiated on 9 Nov 2020 and the FDA has classified it as Class II.
Check your package
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-0737-2021
- FDA event ID
- 86830
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2020
- FDA classified
- 28 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 9 Nov 2020 | Recall initiated by company | |
| 28 Dec 2020 | Classified by FDA | +49 days |
| 6 Jan 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Gauze sponges contained in custom kits may be flaking or fraying.
Product as listed by the FDA
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
Where it was distributed
US Domestic Distribution Only: MO, NC, LA and FL.
Questions about this recall
Is Custom procedure packs, containing banded Raytec 16ply gauze sponges recalled?
Yes. ROi CPS recalled Custom procedure packs, containing banded Raytec 16ply gauze sponges on 9 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0737-2021.
Why was it recalled?
Gauze sponges contained in custom kits may be flaking or fraying.
Which lots are affected?
Lot Numbers: 82466, 83411, 82442, 82504, 82497, 82490, 82592, 82582, 82844, 82832, 82876, 82893, 83058, 83139, 83251, 83138, 83257, 83106, 82886, 83135, 83050, 83264, 82879, 83383, 83271, 83583, 83421, 83560, 83273, 83575, 83576, 82847, 83598, 82472, 82417, 82389, 82473, 82427, 82501, 82496, 82507, 82574, 82478, 82469, 82485, 82584, 82588, 82600, 82597, 82593, 82594, 82606, 82828, 82825, 82882, 83033, 82880, 82887, 83048, 83073, 83042, 83124, 83133, 83095, 83132, 83071, 83238, 83254, 83240, 83232, 83244, 82872, 83222, 82831, 83263, 83111, 83267, 83261, 83274, 83258, 83266, 83388, 83424, 83417, 83426, 83415, 83427, 83557, 83536, 83540, 83418, 83581, 83550, 83428, 83579, 83296, 83268, 83752, 82591, 82589, 82640, 82813, 82513, 82596, 83069, 82852, 83252, 83101, 83293, 83392, 83572, 83120, 83584, 83422, 83955, 82399, 82474, 82403, 82492, 82509, 82470, 82465, 82491, 82575, 82576, 82521, 82525, 82481, 82577, 82500, 82601, 82607, 82595, 82605, 82519, 82523, 82603, 82625, 82888, 83045, 82855, 83066, 82849, 83036, 83049, 82890, 83242, 83235, 83115, 83064, 83046, 83118, 83245, 83126, 83377, 83134, 83389, 83127, 83286, 83269, 83398, 83292, 83285, 83366, 83423, 83391, 83136, 83445, 83283, 83561, 83545, 83585, 83589, 83580, 83944, 83771.
Where was it sold?
US Domestic Distribution Only: MO, NC, LA and FL.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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