Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 (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 | 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 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. |
| 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. |
| 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 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 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 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 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 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 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 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 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 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 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, 3 mL 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 |
| 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 |
| Aug 4, 2021 | Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Mac Medical Supply Co Inc |
| Aug 4, 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod... | Potential for the plunger to draw back after the air has been expelled and reintroduce air back i... | Class I | Cardinal Health |
| Jul 21, 2021 | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,... | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 13, 2021 | Pipeline Flex Embolization Device | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 13, 2021 | EV3 Pipeline Flex Embolization Device with Flex Shield Technology | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 7, 2021 | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... | Class I | Baxter Healthcare Corporation |
| Jun 18, 2021 | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 16, 2021 | Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 7... | The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalp... | Class I | Cardinal Health 200, LLC |
| Jun 14, 2021 | DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 4, 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... | System errors were noted following changes the customers implemented to the configuration of thei... | Class I | Baxter Healthcare Corporation |
| Jun 4, 2021 | Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08... | The patient may be exposed to potential aluminum ion release during warming therapy under certain... | Class I | Eight Medical International BV |
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.