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Browse Device Recalls

590 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 590 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 590 FDA device recalls.

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DateProductReasonClassFirm
Apr 22, 2025 ICU Medical Plum Solos, Item number 400011001; infusion pump Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Nov 6, 2024 ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... Due to finished goods incorrectly packaged and labeled. Class II ICU Medical, Inc.
Oct 22, 2024 Allegedly counterfeit batteries manufactured by CSB batteries being used with... ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... Class I ICU Medical, Inc.
Aug 1, 2022 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 MicroClave Clear Neutral Connector. A bidirectional connector used as an acce... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Aug 1, 2022 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... Due to a manufacturing defect which results in a visible gap between the connector's top and bott... Class II ICU Medical, Inc.
Jun 27, 2022 Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... Ports have a potential for unintended disconnection, inability to connect to or fully engage with... Class II ICU Medical, Inc.
Jun 27, 2022 Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... Ports have a potential for unintended disconnection, inability to connect to or fully engage with... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Pr... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF Spinning Spiros Closed Male Luer - Product Usage: provides access for th... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, A... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides acce... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: prov... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filt... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" -... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLoc... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Sp... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Dri... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PO... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. F... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLo... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave D... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port L... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/Che... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClav... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Dec 2, 2020 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Produ... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Produc... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage:... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Aug 31, 2020 Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.

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.