Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2021 | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging a... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 12, 2021 | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a... | Class II | Covidien Llc |
| Nov 12, 2021 | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 wi... | (1)Start-up problem: Intermittently at start-up of the system, the communication of the control u... | Class II | Philips North America Llc |
| Nov 12, 2021 | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisi... | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly h... | Class II | Philips North America Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1PLDIPC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X3JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U3ESDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator,980X1ENAIQC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980A1ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S1ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENDIPC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980A3ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S3ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X3ENDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U1ENASAA | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U1ESDIUC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X2ESDIEC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Oct 29, 2021 | Wireless Footswtich used with the following Philips Allura Xper and Azurion I... | Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure | Class II | Philips North America Llc |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of stricture... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of stricture... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... | If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... | Class II | Philips North America Llc |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... | If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... | Class II | Philips North America Llc |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictur... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictur... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 21, 2021 | HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strict... | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge... | Class II | Boston Scientific Corporation |
| Oct 19, 2021 | Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Numb... | An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in er... | Class II | InfuTronix LLC |
| Oct 14, 2021 | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of inte... | Endotoxin levels exceeded allowable limits. | Class II | Beeken Biomedical, LLC |
| Oct 13, 2021 | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic... | The firm has received customer reports of performance issues with the affected lot, including inc... | Class II | Instrumentation Laboratory |
| Oct 8, 2021 | bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cat... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xsta... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or c... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surg... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 1, 2021 | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is... | The device is missing grit blasting on the proximal surface of the femoral stem, which may lead t... | Class II | OmniLife Science |
| Sep 29, 2021 | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic... | The firm identified an error in the device temperature monitoring circuitry which is designed to ... | Class II | Covidien Llc |
| Sep 28, 2021 | Atellica IM 1300 Analyzer, SMN 11066001 | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 28, 2021 | Atellica IM 1600 Analyzer, SMN 11066000 | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 24, 2021 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This ... | Class II | Philips Healthcare |
| Sep 24, 2021 | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... | Class II | Philips North America Llc |
| Sep 22, 2021 | ProxiDiagnost N90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | CombiDiagnost R90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 | Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 22, 2021 | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 | Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine t... | Class II | Siemens Healthcare Diagnostics, 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.