Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 8, 2019 | VITROS 250 Chemistry System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 8, 2019 | Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: ... | The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VC... | Class II | Medtronic Navigation, Inc. |
| Jul 8, 2019 | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... | The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 8, 2019 | VITROS 5600 Integrated System, clinical chemistry analyzer | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | Class II | Ortho Clinical Diagnostics |
| Jul 3, 2019 | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected produc... | Perfusion tubing pack was packaged with the incorrect cuvette. | Class III | LivaNova USA Inc. |
| Jul 3, 2019 | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic di... | Error in the default configuration which could lead to the incorrect display of patient master data. | Class II | Heidelberg Engineering GmbH |
| Jul 3, 2019 | SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomograph... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
| Jul 3, 2019 | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... | Class II | Elekta Inc |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
| Jul 3, 2019 | PediaLift Access Device, Device Identifier: B751PDLFT0 | The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the origi... | Class II | PediaLift LLC |
| Jul 3, 2019 | SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tom... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomo... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
| Jul 3, 2019 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... | Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... | Class II | Capso Vision, Inc. |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
| Jul 3, 2019 | SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography sys... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Pr... | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment ... | Class II | Xcision Medical Systems, LLC |
| Jul 3, 2019 | SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomogra... | Potential for four safety-related software issues impacting systems utilizing syngo.CT software v... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
| Jul 2, 2019 | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish R... | Potential for a transducer mis-alignment in certain transvaginal probes. | Class II | GE Healthcare, LLC |
| Jul 2, 2019 | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 0729010... | The firm has become aware that the Snapshot Trackers were not manufactured in accordance with sp... | Class II | Mazor Robotics Ltd |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay... | The firm conducted internal investigations that confirmed customer complaints of quality control ... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 2, 2019 | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | Potential for a transducer mis-alignment in certain transvaginal probes. | Class II | GE Healthcare, LLC |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (T... | QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate I... | Class II | Qiagen Sciences LLC |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 1, 2019 | STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used ... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for perform... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 1163456... | Calibration; it has been determined that the capnographs may have been calibrated during manufact... | Class II | CareFusion 303, Inc. |
| Jul 1, 2019 | HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driv... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used f... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | Erisma- LP posterior fixation system with the below specifically affected pro... | Potential for the polyaxial screw to become disassembled during implant. | Class III | Clariance Inc |
| Jul 1, 2019 | Rusch EasyCath Kit | Potential for product not to be sterile. | Class II | Teleflex Medical |
| Jul 1, 2019 | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI... | The firm became aware of a manufacturing variation in which black and green reloads in select Sta... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2019 | DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regio... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for lac... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceratio... | Potential for sterile packaging to be compromised | Class II | Centurion Medical Products Corporation |
| Jul 1, 2019 | Universal Sexual Health Testing Kit | A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could... | Class II | Privapath Diagnostics Ltd |
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.