Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 9, 2020 | Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
| Mar 5, 2020 | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidan... | No torque was specified for the four screws that connect the gearbox and the mounting flange with... | Class II | Philips North America, LLC |
| Mar 5, 2020 | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service N... | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... | Class II | Philips North America, LLC |
| Mar 5, 2020 | TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System ... | The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Tran... | Class II | Philips North America, LLC |
| Feb 26, 2020 | HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M353... | Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffe... | Class II | Philips North America, LLC |
| Feb 20, 2020 | Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... | Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incor... | Class II | Philips North America, LLC |
| Feb 19, 2020 | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.... | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to ... | Class II | Haemonetics Corporation |
| Feb 13, 2020 | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D... | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blo... | Class II | Insulet Corporation |
| Feb 10, 2020 | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and F... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 10, 2020 | Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed ... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 3, 2020 | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR ... | A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... | Class II | Conformis, Inc. |
| Feb 3, 2020 | iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS ... | A limited number of tibial trays were labeled with an incorrect serial number and were delivered ... | Class II | Conformis, Inc. |
| Jan 29, 2020 | Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used... | The firm is replacing pressure transducers with an improved design due to an increase in customer... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jan 28, 2020 | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an ... | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstru... | Class II | Breas Medical, Inc. |
| Jan 17, 2020 | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, trans... | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier ... | Class II | COVIDIEN LLC |
| Jan 15, 2020 | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 14, 2020 | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips H... | M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid ... | Class II | Philips North America, LLC |
| Jan 13, 2020 | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... | if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorde... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 ... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Allura CV20, system code 722031 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Poly G Integris H5000, System code 72246 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende... | Due to a potential for sterile barrier breach. A complaint was received that indicated the protec... | Class II | Smith & Nephew, Inc. |
| Dec 30, 2019 | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system c... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | OmniDiagnost Eleva System codes 708028 708027 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | UroDiagnost Eleva, system code 708033 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Cardio Vascular-Allura Centron, system code 722400 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Integris Allura 9, system codes 722018 722021 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 24, 2019 | Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an impla... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implan... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 23, 2019 | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN... | Class II | Philips North America, LLC |
| Dec 17, 2019 | AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... | Class II | Boston Scientific Corporation |
| Dec 2, 2019 | PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 | The boxes used by the shipper were not validated for use during transport. | Class II | 3-D Matrix, Inc. |
| Nov 20, 2019 | ProxiDiagnost N90 | Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. | Class II | Philips North America, LLC |
| Nov 18, 2019 | Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product... | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... | Class II | Boston Scientific Corporation |
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.