Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2025 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | Class II | Fresenius Kabi USA, LLC |
| Nov 14, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont... | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious pa... | Class I | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbi... | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious... | Class I | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a chec... | Class II | Fresenius Kabi USA, LLC |
| Sep 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Potential issue that can cause the device to register "phantom" touches in the lower-left corner ... | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| May 12, 2025 | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... | Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... | Class I | Fresenius Kabi USA, LLC |
| Jan 10, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... | Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... | Class I | Fresenius Kabi USA, LLC |
| Dec 6, 2024 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could ... | Class I | Fresenius Kabi USA, LLC |
| Aug 30, 2024 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... | Class I | Fresenius Kabi USA, LLC |
| Aug 1, 2024 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | A defect may cause an uncontrolled medication flow condition which may result in a dose greater t... | Class I | Fresenius Kabi USA, LLC |
| Mar 7, 2024 | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... | Class I | Fresenius Kabi USA, LLC |
| Nov 29, 2023 | Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 | The device may experience mechanical interference on the Fluid Valve pins, which will trigger a P... | Class I | Fresenius Kabi USA, LLC |
| May 10, 2023 | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-S... | Class II | Fresenius Kabi USA, LLC |
| Mar 10, 2023 | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resu... | Class I | Fresenius Kabi USA, LLC |
| Sep 16, 2022 | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop)... | Class II | Fresenius Kabi USA, LLC |
| Sep 8, 2022 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggering an alarm that is ... | Class I | Fresenius Kabi USA, LLC |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... | Class II | Fresenius Kabi USA, LLC |
| Dec 19, 2014 | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 US... | The lot failed pH specification. | Class II | Fresenius Kabi USA, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.