ICU Medical Inc
Complete recall history across all FDA and CPSC categories — 50 total recalls
Recall Summary
ICU Medical Inc 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.
Drug Recalls (15)
FDA drug safety enforcement actions by ICU Medical Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 9, 2022 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ... | Lack of assurance of sterility: Bags have the potential to leak in the flexib... | Class II |
| Sep 3, 2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... | Presence of Particulate Matter: Particulate matter identified as fibers, hair... | Class I |
| Mar 9, 2021 | 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu... | Presence of particulate matter.one confirmed customer report of particulate ... | Class II |
| May 8, 2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter: confirmed customer complaint for the presence... | Class I |
| Oct 25, 2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I |
| Oct 25, 2019 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I |
| Feb 4, 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... | CGMP Deviations | Class II |
| Oct 8, 2018 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... | Lack of Assurance of Sterility; bags have the potential to leak | Class II |
| Oct 8, 2018 | 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... | Lack of Assurance of Sterility; bags have the potential to leak | Class II |
| May 31, 2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... | Lack of assurance of sterility: Bags have potential to leak. | Class II |
| May 31, 2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... | Lack of assurance of sterility: Bags have potential to leak. | Class II |
| May 31, 2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... | Lack of assurance of sterility: Bags have potential to leak. | Class II |
| May 31, 2018 | 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... | Lack of assurance of sterility: Bags have potential to leak. | Class II |
| May 31, 2018 | 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... | Lack of assurance of sterility: Bags have potential to leak. | Class II |
| Jul 26, 2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... | Presence of Particulate Matter; stainless steel | Class II |
Device Recalls (35)
FDA medical device enforcement actions by ICU Medical Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| May 7, 2024 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| May 7, 2024 | Plum 360/A+ spare batteries. Item Number: SUB0000864. | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| May 7, 2024 | Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| Jul 13, 2023 | Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300... | Due to a manufacturing defect of a supplier provided component, there is a po... | Class II |
| Mar 22, 2023 | Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| Mar 22, 2023 | ASM Replacement Battery, Component Number SUB0000594 | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| Mar 22, 2023 | ASM Replacement Battery, Component Number SUB0000864 | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| Mar 22, 2023 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... | Due to a manufacturing defect from the battery supplier, affected batteries m... | Class I |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sa... | Class II |
| Nov 8, 2018 | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I... | There have been reports of distal occlusion alarms during the use of SAPPHIRE... | Class II |
| Aug 1, 2018 | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... | A software malfunction of the infuser when used with a MedNet Custom Drug Lib... | Class II |
| Oct 30, 2017 | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is... | Class II |
| Oct 30, 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Nu... | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can... | Class II |
| Jun 15, 2017 | Plum 360 Infusion System | Potential for the Connectivity Engine Module of the affected unit to disengag... | 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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