Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part ... | The subject product lots are being recalled because they received a higher than specified irradia... | Class II | DePuy Orthopaedics, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX, REF 324 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 AUX, REF 306 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES (Med ES Main), REF 323 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 Main, REF 303 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX To... | Due to an increase in complaints of door latch assembly failures that may cause the doors to be l... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med... | Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermo... | There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... | Class II | Edwards Lifesciences, LLC |
| Feb 14, 2023 | BD Pyxis Med 4000 Auxiliary (AUX), REF 314 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 | The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses ... | Class II | CooperVision, Inc. |
| Feb 14, 2023 | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multi... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 14, 2023 | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedur... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 14, 2023 | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap... | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a stand... | Class II | Brainlab AG |
| Feb 14, 2023 | Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Therm... | There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... | Class II | Edwards Lifesciences, LLC |
| Feb 14, 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on ... | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliabi... | Class II | Defibtech, LLC |
| Feb 14, 2023 | BD Pyxis Med ES Auxiliary (AUX), REF 343 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter... | Incorrect Unique Device Identifier/GTIN code was used on product. | Class II | Pro-Dex Inc |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 13, 2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5... | It has come to CooperSurgical's attention that the affected Product may contain a medium other th... | Class II | CooperSurgical, Inc. |
| Feb 13, 2023 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ... | Class II | Maquet Medical Systems USA |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 10, 2023 | MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Mod... | The current luer fittings and adaptors allow for the possibility of the air line to be misconnect... | Class II | Unetixs Vascular, Inc. |
| Feb 10, 2023 | COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. ... | Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. | Class II | Covidien |
| Feb 10, 2023 | MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number... | The current luer fittings and adaptors allow for the possibility of the air line to be misconnect... | Class II | Unetixs Vascular, Inc. |
| Feb 10, 2023 | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... | A limited number of remediated Philips DreamStation units may experience communication issues whe... | Class I | Philips Respironics, Inc. |
| Feb 10, 2023 | MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device,... | The current luer fittings and adaptors allow for the possibility of the air line to be misconnect... | Class II | Unetixs Vascular, Inc. |
| Feb 10, 2023 | MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Numb... | The current luer fittings and adaptors allow for the possibility of the air line to be misconnect... | Class II | Unetixs Vascular, Inc. |
| Feb 10, 2023 | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model ... | Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the li... | Class II | Intuitive Surgical, Inc. |
| Feb 10, 2023 | Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software... | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may de... | Class II | Sensus Healthcare, Inc. |
| Feb 9, 2023 | FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use... | If using affected glucose monitoring app on Android 13 Operating System, extended periods of sign... | Class II | Abbott Diabetes Care, Inc. |
| Feb 9, 2023 | DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B | The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage cause... | Class II | DeRoyal Industries Inc |
| Feb 8, 2023 | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile... | Class I | Datascope Corp. |
| Feb 7, 2023 | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic ex... | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. S... | Class II | Stryker GmbH |
| Feb 7, 2023 | CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, T... | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Model... | Class II | St. Jude Medical |
| Feb 7, 2023 | Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-08... | An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P... | Class I | Datascope Corp. |
| Feb 7, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile... | Class I | Datascope Corp. |
| Feb 7, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There have been reported failures of the high pressure helium regulator, which may cause a helium... | Class II | Datascope Corp. |
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.