Clinical Innovations, LLC
Complete recall history across all FDA and CPSC categories — 8 total recalls
Recall Summary
Clinical Innovations, LLC appears in recall records across 2 categories. 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.
Food Recalls (3)
FDA food safety enforcement actions by Clinical Innovations, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 19, 2022 | Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml ... | Firm received complaints of leaking, black liquid, and black particulates in ... | Class II |
| Jul 19, 2022 | Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Eac... | Firm received complaints of leaking cups, black liquid, and black particulate... | Class II |
| Jul 19, 2022 | Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml ... | Firm received complaints of leaking, black liquid, and black particulates in ... | Class II |
Device Recalls (5)
FDA medical device enforcement actions by Clinical Innovations, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 13, 2020 | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Mem... | Possible false negative or false positive results. The incorrect sample coll... | Class II |
| Aug 6, 2019 | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: ... | There is a potential for loss of vacuum or failure to generate vacuum when us... | Class II |
| May 30, 2019 | Clearview Total Uterine Manipulator (model UM750), The device is labeled in ... | An incorrect component used during manufacturing. The uterine manipulator tip... | Class II |
| Jan 5, 2015 | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended f... | Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade... | Class II |
| Dec 30, 2014 | Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx On... | Potential for a balloon leak in all lots of (CTS-1000) manufactured since Aug... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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