Browse Device Recalls

3,435 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,435 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 3,435 FDA device recalls — Class I.

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DateProductReasonClassFirm
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980S1ENDICU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U1ENASAA Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980S3ENDICU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator,980X1ENAIQC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980A3ENNISB Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980A1ENNISB Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Oct 14, 2021 IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Lumenis, Inc.
Oct 1, 2021 Ellume COVID-19 Home Test Due to a higher rate of false positive test results. Class I ELLUME LTD
Sep 22, 2021 ROSA One 3.1 Brain application The device is intended for the spatial posi... The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le... Class I MEDTECH SAS
Sep 21, 2021 Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card... A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run... Class I Datascope Corp.
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 9, 2021 GENOSYL DS (Delivery System) console, for use as a vasodilator. Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery ... Class I Vero Biotech, LLC
Sep 7, 2021 Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I DJO, LLC
Sep 7, 2021 GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I DJO, LLC
Sep 2, 2021 DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming... DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming Syst... Class I Deroyal Industries, Inc. Lafollette
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Aug 27, 2021 EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Descripti... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I North Coast Medical Inc
Aug 27, 2021 Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL;... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I North Coast Medical Inc
Aug 25, 2021 Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Accelerated Care Plus Corporation
Aug 24, 2021 ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmissio... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 24, 2021 ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 23, 2021 Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in ac... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Aesthetics Systems Usa Inc
Aug 20, 2021 LiquaSonic Ultrasound Gel 5L, Model No. 001222 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 20, 2021 LiquaSonic Ultrasound Gel 250mL, Model No. 001205 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 19, 2021 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... Class I Windstone Medical Packaging, Inc.
Aug 18, 2021 Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultr... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Scrip Inc
Aug 18, 2021 Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultr... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Scrip Inc
Aug 13, 2021 Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137... There is a potential for distal end of catheters to fracture and become detached. Class I IMPERATIVE CARE INC
Aug 12, 2021 EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiP... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I AMTEC SALES Inc
Aug 11, 2021 EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Red Medical Supplies
Aug 11, 2021 EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Red Medical Supplies
Aug 11, 2021 EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Red Medical Supplies
Aug 6, 2021 NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR... There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... Class I Smiths Medical ASD Inc.
Aug 6, 2021 NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... Class I Smiths Medical ASD Inc.
Aug 5, 2021 AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product ... Some devices may be associated with high and unexpected resistance to gas flow during clinical us... Class I Armstrong Medical Services Limited
Aug 4, 2021 Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ... Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... Class I Cardinal Health

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.