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 |
|---|---|---|---|---|
| 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 |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Va... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Azurion series (within the limits of the used Operation Room table) are i... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 13, 2021 | The Allura Xper series is intended for use on human patients to perform: "Vas... | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. Th... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
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.