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 |
|---|---|---|---|---|
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Pre... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit V... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 2, 2020 | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagn... | Thermo switches in the main power supply for the system may be incorrectly installed, resulting i... | Class II | Philips North America, LLC |
| May 27, 2020 | RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens M... | The scanner is not confirming the integrity of read barcode data using the check-digit when readi... | Class II | Siemens Healthcare Diagnostics Inc |
| May 22, 2020 | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interfac... | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| May 19, 2020 | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The Su... | Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that ... | Class II | Philips North America, LLC |
| May 15, 2020 | MEVION S250i, MEVION S250; Proton Radiation Treatment System | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correctio... | Class II | Mevion Medical Systems, Inc. |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 40... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL F... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Produ... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code:... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm)... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm),... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Se... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 27, 2020 | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A,... | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv... | Class II | Philips North America, LLC |
| Apr 23, 2020 | ProxiDiagnost N90, UDI 706100 | The thermo switches in the three-phase transformer, which normally aid in powering down the Syste... | Class II | Philips North America, LLC |
| Apr 21, 2020 | Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product ... | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv... | Class II | Philips North America, LLC |
| Apr 20, 2020 | Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an... | Internal Paddles may wear over time and may not be safe or ready for use, unless the directions i... | Class II | Philips North America, LLC |
| Apr 13, 2020 | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog... | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... | Class II | Philips North America, LLC |
| Apr 13, 2020 | Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c... | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... | Class II | Philips North America, LLC |
| Apr 13, 2020 | Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product U... | The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1... | Class II | Philips North America, LLC |
| Apr 10, 2020 | Philips Zenition 50, System code 718096 - Product Usage: The devices are used... | When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... | Class II | Philips North America, LLC |
| Apr 10, 2020 | HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a componen... | Damaged ESD bags used for storing components in Processor PCA Replacement Kits | Class II | Philips North America, LLC |
| Apr 10, 2020 | Philips Zenition 70, System code 718133 - Product Usage: The devices are used... | When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or mor... | Class II | Philips North America, LLC |
| Apr 7, 2020 | Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 72001... | If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury. | Class II | Philips North America, LLC |
| Apr 6, 2020 | Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model ... | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... | Class II | Philips North America, LLC |
| Apr 6, 2020 | Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI ... | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... | Class II | Philips North America, LLC |
| Apr 6, 2020 | Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... | Class II | Philips North America, LLC |
| Apr 3, 2020 | Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... | When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and... | Class II | Philips North America, LLC |
| Apr 2, 2020 | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Numbe... | After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... | Class II | Insulet Corporation |
| Apr 2, 2020 | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number ... | After the device has been in use for about 2 months, data processing in the PDM can be slowed suc... | Class II | Insulet Corporation |
| Mar 30, 2020 | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be... | To reinforce existing instructions within the Directions for Use (DFU) and provide further guidan... | Class II | Boston Scientific Corporation |
| Mar 23, 2020 | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... | There has been an increased trend in reports of catheters failing to deflate during use, which ma... | Class I | LeMaitre Vascular, Inc. |
| Mar 17, 2020 | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Space between the device and the packaging permits excessive movement which could potentially lea... | Class II | Smith & Nephew, Inc. |
| Mar 17, 2020 | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 | Space between the device and the packaging permits excessive movement which could potentially lea... | Class II | Smith & Nephew, Inc. |
| Mar 12, 2020 | Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 19... | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 12, 2020 | Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T ... | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 9, 2020 | Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... | 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 6FX24CM with .038 Sensor UPN: M00617526... | 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 STR/150CM UPN: M00667... | An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... | Class II | Boston Scientific |
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.