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 |
|---|---|---|---|---|
| Jun 8, 2022 | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. F... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ch... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vasc... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For v... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For va... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 1, 2022 | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Ava... | There is a potential reversal of the O2 and air cylinder pressure transducer connections. | Class I | GE Healthcare, LLC |
| May 16, 2022 | Drager SafeStar 55, Catalog No. MP01790 | Possible occlusion of filters due to manufacturing error. | Class I | Draeger Medical, Inc. |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| May 2, 2022 | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| May 2, 2022 | Clean Catch Urine Kit NS 178489, AHMU58A | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| May 2, 2022 | Flow-e Anesthesia System : Intended for use in administering anesthesia while... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| May 2, 2022 | Flow-c Anesthesia System : intended for use in administering anesthesia whil... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| Apr 29, 2022 | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 18, 2022 | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 18, 2022 | Replacement back up batteries distributed on or after April 1, 2019, for CARE... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 18, 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 14, 2022 | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... | The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... | Class I | Medtronic Inc |
| Apr 9, 2022 | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 9, 2022 | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 6, 2022 | Accula SARS-CoV-2 Test, REF: COV4100 | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay ... | Class I | MESA BIOTECH, INC |
| Apr 5, 2022 | Sara Plus Active Floor Lift | The device may emit smoke or ignite. | Class I | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Apr 1, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CL... | Class I | CELLTRION USA INC |
| Mar 30, 2022 | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, ... | There is a potential that the proximal marker may separate from the imaging catheter | Class I | Abbott Vascular |
| Mar 25, 2022 | Puritan Bennett 980 Series Ventilator | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display duri... | Class I | Medtronic formerly Covidien |
| Mar 21, 2022 | Avanos Cortrak 2 Enteral Access System (EAS) | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK ... | Class I | Avanos Medical, Inc. |
| Mar 14, 2022 | Cub 2 Enclosed Bed Canopy System | Due potential misuse of the product, firm is updating warnings and precautions booklet for produc... | Class I | Sensory Medical Inc |
| Mar 4, 2022 | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVI... | The product was distributed without FDA authorization or clearance for marketing and distribution... | Class I | SML Distribution, LLC |
| Mar 3, 2022 | iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 ... | Firm has observed increased rate of customer complaints related to separation of the balloon or c... | Class I | Atrium Medical Corporation |
| Mar 3, 2022 | Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Numb... | Firm has observed increased rate of customer complaints related to separation of the balloon or c... | Class I | Atrium Medical Corporation |
| Mar 2, 2022 | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... | There is potential for the capsule bond to break during the procedure. | Class I | Medtronic Inc |
| Feb 28, 2022 | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Jan 31, 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... | Class I | SD Biosensor, Inc. |
| Jan 27, 2022 | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit | The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purp... | Class I | E25Bio, Inc. |
| Jan 24, 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 24, 2022 | Philips Respironics V60 Plus Ventilator Part Number 1138747 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 13, 2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, Inc. |
| Jan 13, 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... | Class I | Lusys Laboratories, 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.