Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 11, 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Par... | Due to a defect identified on the EPG controller printed circuit board assembly, device performan... | Class I | Synapse Biomedical Inc |
| Jul 10, 2022 | INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantabl... | Higher than expected flow rate. | Class I | Intera Oncology, Inc. |
| Jun 28, 2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... | Battery performance issues. Battery electrical faults render it unable to power the controller, u... | Class I | Heartware, Inc. |
| Jun 27, 2022 | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | Ventilator status indicator board can become loose, which could lead to water ingress (disinfecta... | Class I | Hamilton Medical AG |
| Jun 22, 2022 | CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... | Class I | Integra LifeSciences Corp. |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... | There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... | Class I | Baxter Healthcare Corporation |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 20, 2022 | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle ... | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from in... | Class I | Bard Access Systems, Inc. |
| Jun 15, 2022 | SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral... | Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to c... | Class I | North American Diagnostics |
| 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 | 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 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 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 | Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and c... | 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 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 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 | 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 |
| 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 | 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 | 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 |
| 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 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 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 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 | 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 | 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 |
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.