Fenwal Inc
Complete recall history across all FDA and CPSC categories — 10 total recalls
Fenwal Inc 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 (10)
FDA medical device enforcement actions by Fenwal Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 14, 2023 | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multi... | Potential for centrifuge packs to develop a stress leak for certain lots of A... | Class II |
| Feb 14, 2023 | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedur... | Potential for centrifuge packs to develop a stress leak for certain lots of A... | Class II |
| Feb 25, 2021 | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the col... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centr... | Class II |
| Feb 25, 2021 | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centr... | Class II |
| Feb 25, 2021 | Amicus Exchange Kit - Product Usage: intended for use in the collection of bl... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centr... | Class II |
| Jun 24, 2019 | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1... | The firm is correcting four software anomalies and KVO (keep vein open) end o... | Class I |
| Jun 24, 2019 | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... | The firm is correcting four software anomalies and KVO (keep vein open) end o... | Class I |
| Mar 5, 2019 | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled ... | Based on internal investigations, Fresenius Kabi has identified a multifacete... | Class II |
| Feb 11, 2019 | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autot... | The optional Vacuum Unit may stop working and display the failure message "Fa... | Class II |
| May 24, 2013 | AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of ... | 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.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.