Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall Zenition 50 & 70 Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall Integris-Allura IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall Allura Xper IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall Azurion IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall Veradius Unity Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereGuam, Puerto Rico and US Virgin Islands
- Medical device recall BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. Due to walkers not meeting product specifications. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report41 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Zephyr Endobronchial Valve (EBV) 5.5-LP Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report22 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, Colorado, Florida, Iowa, Illinois, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall VITROS Chemistry Products Lipase Slides Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Tennessee, Texas and Vermont
- Medical device recall Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information… Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Fogarty Thru-Lumen Embolectomy Catheter Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM An error was identified on the expiration date of the product label. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DJO EMPOWR Knee Punch Handle Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report24 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Mississippi, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Monitron II Waveform Analyzer Note this recall occurred in 2020 and 2021. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereCalifornia, Maryland, Mississippi and North Dakota
- Medical device recall Alcon Custom-Pak, Surgical Procedure Pack Custom surgical procedure packs contain latex gloves but are labeled as “latex free”. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportVirginiathe one state its words name PublishedNov 15, 2023ClassClass IIStatusOngoingWhereVirginia
- Medical device recall CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall AT HOME MARIJUANA TEST STRIP Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall FIXODENT ORG CREAM 2.4OZ Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall VERIQUICK PREGNANCY TEST 1CT Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall DENTEMP ONE STEP .077OZ Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall FIRST RESPONSE 2 CT Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall GOODSENSE DENTURE CLEANSER GRN TAB 40CT Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall ARC TEETH WHITENING PEN 0.06 FL OZ Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall MEDIC’s CHOICE CONTACT LENS SOLUTION 12FLOZ Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall ORAL B MOUTH SORE RINSE 237ML Products were stored outside of labeled temperature requirements. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Louisiana, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images. Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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