Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 | 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 | 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 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 | 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 | 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 | 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 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 |
| 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 3, 2021 | HeartWare HVAD Outflow Graft, REF MCS1725OG | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Accessories, REF MCS1753AK | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF 1104JP | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1125 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1153 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| May 19, 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Reports received of NO measured below desired dose during transition between primary console and ... | Class I | Vero Biotech, LLC |
| May 17, 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... | Class I | Smiths Medical ASD Inc. |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 7, 2021 | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 4, 2021 | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... | The component part numbers intended for shipment to a third-party, where they are further process... | Class I | Medtronic Vascular |
| Apr 27, 2021 | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... | Class I | Quidel Corporation |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatog... | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not author... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatogr... | Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution ... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 12, 2021 | VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of o... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 9, 2021 | FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part ... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAK... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 7T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 3T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
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.