Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2021 | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating... | The supplier informed them of possible deviations of the parameters/processes defined for ethylen... | Class II | Spes Medica |
| Apr 7, 2021 | REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Ext... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card... | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 7, 2021 | REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positionin... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intende... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 7, 2021 | REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positionin... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 c... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | RayStation standalone software radiation therapy treatment planning system. ... | When using more than one plan in a treatment course, the Total dose display in Dose tracking ma... | Class II | RAYSEARCH LABORATORIES AB |
| Apr 7, 2021 | REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: in... | Recall reason is possible sporadic false negative conventional troponin results. Roche has confir... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 7, 2021 | REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 ... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location Syste... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 7, 2021 | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lum... | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced result... | Class II | Bard Access Systems Inc. |
| Apr 6, 2021 | Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Materi... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... | The firm received a complaint regarding particulate found in the packaging foam that could contam... | Class II | LeMaitre Vascular, Inc. |
| Apr 6, 2021 | Programmers - Product Usage: used to treat arrhythmias related to bradycardia... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Numbe... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 5, 2021 | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliar... | The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endopros... | Class II | W.L. Gore & Associates, Inc. |
| Apr 1, 2021 | Scooter | Seat baseplate pin has broken in the field. | Class II | Merits Holdings Co. dba Merits Health Products,... |
| Apr 1, 2021 | DirectInject consists of a sterile dual paste system which is calcium phospha... | Inability for the user to inject the paste from the syringe into the target location. | Class II | Stryker Leibinger GmbH & Co. KG |
| Apr 1, 2021 | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF:... | single use devices labeled as sterile may not have been adequately sterilized | Class II | CLINICAL LASERTHERMIA SYSTEMS AB |
| Apr 1, 2021 | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used ... | single use devices labeled as sterile may not have been adequately sterilized | Class II | CLINICAL LASERTHERMIA SYSTEMS AB |
| Apr 1, 2021 | Power Wheelchair | Seat baseplate pin has broken in the field. | Class II | Merits Holdings Co. dba Merits Health Products,... |
| Apr 1, 2021 | Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Pro... | single use devices labeled as sterile may not have been adequately sterilized | Class II | CLINICAL LASERTHERMIA SYSTEMS AB |
| Mar 31, 2021 | Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and b... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | SoftCytogenetics | Software is given wrong results going out to HIS on test that had reruns. | Class II | Soft Computer Consultants, Inc. |
| Mar 31, 2021 | Palm Cups - Product Usage: intended to be used to percuss the chest wall to m... | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 31, 2021 | ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during an... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... | Devices do not meet IEC 60601-2-27 requirements as labeled. | Class II | Welch Allyn Inc Mortara |
| Mar 31, 2021 | HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD 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.