ROi CPS LLC recalls
Every recall we track for ROi CPS LLC — 86 in all, from 2020–2024 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from ROi CPS LLC peaked in 2022 (51); 86 since 2017. 1% rated “stop using now”.
All FDA recall records for ROi CPS LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 4 | 1 | 6 |
| 2021 | 0 | 3 | 4 | 7 | 14 |
| 2022 | 1 | 2 | 8 | 40 | 51 |
| 2023 | 0 | 3 | 7 | 2 | 12 |
| 2024 | 0 | 1 | 1 | 1 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled ROi CPS LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ROi CPS LLC recalls
28 shown- Use cautionMedical device
ROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to
ROi CPS recalls newborn kits with Neo-Tee Resuscitator due to potential loss of positive pressure causing ineffective ventilation. Affected items have specific lot numbers and expiration dates.
ROi CPSDec 26, 2024 - UnratedMedical device
ROi CPS LLC recalls regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
ROi CPS recalls medical convenience kits containing Merit syringes (Jiangsu Shenli Medical Production) due to potential safety risks. Affected items have specific lot numbers and item numbers. Consumers should check their kits for these details.
ROi CPSJul 24, 2024 - Lower riskMedical device
ROi CPS LLC recalls Regard Kit containing the Microtek decanter
ROi CPS recalls Regard Kit with Microtek decanter due to pin holes and tears in sterile packaging that can't be seen. Affected units have specific lot numbers and expiration dates.
ROi CPSJun 17, 2024 - UnratedMedical device
ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit
ROi CPS recalls surgical convenience kits (Item 800943001) due to a component previously recalled by Nurse Assist. Affected kits have specific lot numbers and UDI/DI codes.
ROi CPSDec 18, 2023 - UnratedMedical device
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
ROi CPS recalls Regard Dressing change kits with specific item numbers due to irrigation solution component issues. Affected kits may have safety concerns.
ROi CPSNov 20, 2023 - Use cautionMedical device
ROi CPS LLC recalls Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Regard CV PK cardiovascular convenience kits with specific item numbers and lot numbers recalled due to insufficient setup instructions for chest drains, potentially causing injury.
ROi CPSSep 21, 2023 - Lower riskMedical device
ROi CPS LLC recalls GS0008 2Y - Burn Pack - STL, Item Number 880082025
ROi CPS recalls Burn Packs with Zimmer Dermatome Blades due to 38 complaints about thin, non-uniform skin grafts. Affected units have specific item numbers and lot dates.
ROi CPSSep 11, 2023 - Lower riskMedical device
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
ROi CPS recalls sterile surgical convenience kits (Item 800706005, LD0091E) where light handle covers may detach during use. Affected lots expire by October 2024.
ROi CPSMar 22, 2023 - UnratedMedical device
ROi CPS LLC recalls regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
ROi CPS LLC recalls gastric surgery convenience kits containing 3M surgical drapes due to potential safety concerns. Affected items include model GS00137W with specific lot numbers and expiration dates.
ROi CPS LLCOct 20, 2022 - Lower riskMedical device
ROi CPS LLC recalls Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017,
ROi CPS recalls two nonsterile convenience kits with sterile components mistakenly packaged in nonsterile kits. This could lead to infection risks during medical procedures.
ROi CPSJun 3, 2022 - Lower riskMedical device
ROi CPS LLC recalls regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
ROi CPS recalls sterile CV Minor Kit (Item #800774001) due to nonsterile component packaging. Affected kits may pose infection risks if used without proper sterilization.
ROi CPSMay 20, 2022 - UnratedMedical device
ROi CPS LLC recalls regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
ROi CPS recalls reusable RT Bronch cleaning kits with item number 830086003 due to safety concerns. Learn about affected products and required actions.
ROi CPSMay 3, 2022 - Stop using nowMedical device
ROi CPS LLC recalls Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/
Conmed recalls gastrobypass needles with potential electrode detachment during use. Affected items include specific model numbers and lot dates. Stop using immediately to prevent injury.
ROi CPSMay 3, 2022 - Lower riskMedical device
ROi CPS LLC recalls Regard brand CABG Pack A and B - Spartanburg
Regard CABG Pack A and B products shipped with incorrect packaging may cause improper assembly. Affected units include specific item numbers and lots. Contact manufacturer for details.
RegardMar 21, 2022 - UnratedMedical device
ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013,
regard recalls specific IV start kits due to potential inadequacy in validation of test methods used during manufacturing. Affected kits include certain lot numbers from 2022-2023.
regardMar 18, 2022 - UnratedMedical device
ROi CPS LLC recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices
ROi CPS recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices due to packaging in convenience kits. Affected kits include specific item numbers and lots.
ROi CPSFeb 24, 2022 - Lower riskMedical device
ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
ROi CPS recalls Regard TOTAL HIP - SPRINGFIELD kits with incorrect labeling on individual kits. This mislabeling may cause confusion in surgical use. Affected kits have specific item and lot numbers.
ROi CPSJan 13, 2022 - Lower riskMedical device
ROi CPS LLC recalls Regard, T AND A - Rogers, sterilized convenience kits
ROi CPS recalls sterilized convenience kits with missing rubber latex warning labels. Affected kits may not alert users to latex allergy risks. Contact for replacement.
ROi CPSNov 30, 2021 - Lower riskMedical device
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
ROi CPS recalls newborn kits with non-sterile needles. This may cause infections if used for medical procedures. Affected kits have specific item numbers and expiration dates.
ROi CPSNov 4, 2021 - UnratedMedical device
ROi CPS LLC recalls REGARD Vitrectomy Tray
ROi CPS LLC recalls specific lots of Vitrectomy Trays due to povidone-iodine swabstick used in production being out of specifications.
ROi CPS LLCAug 10, 2021 - Use cautionMedical device
ROi CPS LLC recalls Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Regard NEWBORN KIT (LD00201K) with infant heel warmer may cause burns if used too close to face or infant. Recalled lot numbers: 77906K, 78673K, 79327K, 80825K.
RegardJun 14, 2021 - Lower riskMedical device
ROi CPS LLC recalls Regard Dressing Change Tray
ROi CPS recalls Regard Dressing Change Trays with specific lot numbers due to potential package integrity issues from ChloraPrep applicators.
ROi CPSMar 26, 2021 - Lower riskMedical device
ROi CPS LLC recalls Regard, Item Number 830067009, custom cardiovascular procedure kit
ROi CPS recalls Regard cardiovascular procedure kits with potential slits in drapes that could breach sterile barriers during use. Affected kits have lot number 75818I and expire 05/18/2021.
ROi CPSMar 4, 2021 - Lower riskMedical device
ROi CPS LLC recalls Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot #
ROi CPS recalls custom procedure packs with banded 4x4 Raytec 16ply gauze sponges that may flake or fray. Affected items include specific models and lot numbers listed in the recall notice.
ROi CPSNov 9, 2020 - Lower riskMedical device
ROi CPS LLC recalls Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
ROi CPS recalls Regard obstetric gynecologic instruments with incorrect expiration dates. Affected labor and delivery kits may expire prematurely.
ROi CPSOct 12, 2020 - Lower riskMedical device
ROi CPS LLC recalls Respirator Crash Cart Kit
ROi CPS recalls specific Respirator Crash Cart Kits with incorrect expiration dates that may expire before other components. Affected kits have lot numbers 77127, 74813, and 63168. Contact for replacement.
ROi CPSMay 19, 2020 - UnratedMedical device
ROi CPS LLC recalls Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
ROi CPS recalls Regard CVC Triple Lumen 20CM non Sulfa-Mercy items with lot numbers 68336DRW. These items contain PosiFlush syringes from a previous BD recall. Consumers should check their lot numbers and contact ROi CPS for details.
ROi CPSApr 20, 2020 - Use cautionMedical device
ROi CPS LLC recalls Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER -
ROi CPS LLC recalls custom procedure packs with Clearlink Continu-Flo devices due to potential incorrect use during surgical procedures. Affected items include specific model numbers and lot numbers.
ROi CPSJan 3, 2020
ROi CPS LLC recall questions
How many recalls has ROi CPS LLC had?
86 recalls from ROi CPS LLC are on record with U.S. safety agencies, from 2020–2024.
What is the most recent ROi CPS LLC recall?
ROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to, dated Dec 26, 2024. Every ROi CPS LLC recall is listed on this page, newest first.
What should I do if I have a recalled ROi CPS LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ROi CPS LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.