ROi CPS LLC 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, MA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, MA
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
ROi CPS LLC is recalling Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Ite due to Gauze sponges contained in custom kits may be flaking or fraying.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Gauze sponges contained in custom kits may be flaking or fraying.
Recommended Action
Per FDA guidance
ROi CPS, LLC on 11/17/2020 sent a notice to its customers with the following instructions: Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the ROi Custom Procedure Kit manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. REPLY: If the affected kits are identified, please notify ROi CPS, LLC of the quantity on hand by completing the reply form included in this notice. Please email this form to lacy.stewart@roiscs .com . a. If you do not have inventory, please return the form indicating "O" affected inventory at your facility. b. A label template is included with this notice for use in labeling affected kits. The template can be provided to the end users for application to the affected kits in their inventory. 3. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 4. END USERS: End users are instructed not to use the affected Raytec Gauze. Users should remove the affected 4X4 Raytec Gauze, discard and pull replacement product from sterile supply. Post this notice in all areas where the affected kits are used and or stored.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, LA, MO, NC
Page updated: Jan 10, 2026