Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF G... | A service unit was potentially improperly tested and calibrated during manufacturing on a failed ... | Class II | Solta Medical Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXI... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 15, 2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-... | Class II | Pro-Dex Inc |
| Feb 15, 2023 | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1... | The subject product lots are being recalled because they received a higher than specified irradia... | Class II | DePuy Orthopaedics, Inc. |
| Feb 15, 2023 | FoundationOne Companion Diagnostic (F1CDx) | An incorrect negative claim was identified on the claims page; the device variant information was... | Class II | Foundation Medicine, Inc. |
| 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 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Nu... | The subject product lots are being recalled because they received a higher than specified irradia... | Class II | DePuy Orthopaedics, Inc. |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part N... | The subject product lots are being recalled because they received a higher than specified irradia... | Class II | DePuy Orthopaedics, Inc. |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part N... | The subject product lots are being recalled because they received a higher than specified irradia... | Class II | DePuy Orthopaedics, Inc. |
| Feb 15, 2023 | Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A | Product that was built for design verification testing was inadvertently distributed to customers. | Class II | Merit Medical Systems, 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 (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 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 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 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 | 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 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 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 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 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 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 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 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 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 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 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 |
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.