ROi CPS LLC
Complete recall history across all FDA and CPSC categories — 86 total recalls
ROi CPS LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (86)
FDA medical device enforcement actions by ROi CPS LLC. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 26, 2024 | regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... | There is a potential for the Inline Controller to be using the spring out of ... | Class I |
| Jul 24, 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... | Medical convenience kits were distributed with Merit syringes (manufactured b... | Class II |
| Jun 17, 2024 | Regard Kit containing the Microtek decanter | Decanters may have pin holes and tears in sterile packaging that cannot be id... | Class II |
| Dec 18, 2023 | regard Operative LAP, Item Number 800943001; surgical convenience kit | Surgical convenience kits were manufactured with a component which was subseq... | Class I |
| Nov 20, 2023 | Regard Dressing change kit, Item Number 800026006 | ROi CPS manufactured and distributed medical convenience kits with an irrigat... | Class I |
| Sep 21, 2023 | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular conveni... | Specific Regard kits contain the Gentige Chest Drain Products being recalled ... | Class II |
| Sep 11, 2023 | GS0008 2Y - Burn Pack - STL, Item Number 880082025 | Medical convenience kit contains Zimmer Dermatome Blades which were recalled ... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C -... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS0101... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR0... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS007... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C -... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E -... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH... | The recalling firm was notified by their supplier that the light handle cover... | Class II |
| Oct 20, 2022 | ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenien... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenien... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery ... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery ... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery conve... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery c... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; orth... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho sur... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery c... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery conveni... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 83009900... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
| Oct 20, 2022 | regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes whic... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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