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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.