Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Patient Positioning System with KRC2 controller using software versions 2.3.1... | Communications between the Patient Positioning System and the accuracy filter can periodically fa... | Class II | Forte Automation Systems Inc |
| Sep 5, 2017 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 550 ml Sterile¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 15 ml Normal Saline ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 1, 2017 | Respire Pink+ Hard Oral Sleep Apnea Device | Potential for device breakage during use | Class II | Respire Medical |
| Sep 1, 2017 | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution... | Class II | Baxter Healthcare Corp |
| Sep 1, 2017 | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. | Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to... | Class II | Elekta Inc |
| Sep 1, 2017 | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS I... | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
| Sep 1, 2017 | Respire Pink+ Hard/Soft Oral Sleep Apnea Device | Potential for device breakage during use | Class II | Respire Medical |
| Sep 1, 2017 | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500... | The recommended storage temperature on the label is incorrect. | Class II | Aaren Scientific Inc. |
| Sep 1, 2017 | Respire Pink H/S Oral Sleep Apnea Device | Potential for device breakage during use | Class II | Respire Medical |
| Sep 1, 2017 | Respire Pink H/S Oral Sleep Apnea Device | Potential for device breakage during use | Class II | Respire Medical |
| Sep 1, 2017 | Respire Pink Series EF+ Oral Sleep Apnea Device. | Potential for device breakage during use | Class II | Respire Medical |
| Sep 1, 2017 | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
| Sep 1, 2017 | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling... | The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.... | Class II | Aesculap Implant Systems LLC |
| Sep 1, 2017 | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com... | The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la... | Class III | CooperVision Inc. |
| Aug 31, 2017 | Syngo.via systems with SW VB20A | A software update was released on August 22, 2017. Performing this software installation and upgr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulde... | Potentially mislabeled. | Class II | Exactech, Inc. |
| Aug 31, 2017 | Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder... | Potentially mislabeled. | Class II | Exactech, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set i... | Leakage of FMS gravity tub sets (281113) at the bulb and tube connection | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 31, 2017 | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... | Class II | ICU Medical, Inc. |
| Aug 31, 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis... | The affected lots are being recalled because the epiphysis may not assemble to the stem, which ma... | Class II | DePuy Orthopaedics, Inc. |
| Aug 31, 2017 | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrica... | A shipment of LCSU 4 suction units and canisters attempted importation into the United States but... | Class II | Laerdal Medical Corporation |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the phys... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis... | The affected lots are being recalled because the epiphysis may not assemble to the stem, which ma... | Class II | DePuy Orthopaedics, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 30, 2017 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... | The device had an incorrect printed calibration value on the calibration certificate. | Class II | Carl Zeiss Meditec AG |
| Aug 29, 2017 | BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL... | A limited portion of the lot was manufactured with less than the required amount of K2EDTA additi... | Class II | Becton Dickinson & Company |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical 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.