Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers Their is a potential that the implant curved stem may be oriented incorrectly. Class IIFDA’s classMar 6, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 6, 2024ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Michigan, Nevada, Tennessee and Texas
- Medical device recall USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers Their is a potential that the implant curved stem may be oriented incorrectly. Class IIFDA’s classMar 6, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 6, 2024ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Michigan, Nevada, Tennessee and Texas
- Medical device recall Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following Distribution without Pre-Market Clearance Class IIFDA’s classMar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with… Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery Class IIFDA’s classMar 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana and Washington named
- Medical device recall Baxter Exactamix Pro 1200 An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oregon, South Dakota, Texas, Washington and Wisconsin
- Medical device recall Baxter Exactamix Pro 2400 An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report22 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oregon, South Dakota, Texas, Washington and Wisconsin
- Medical device recall Argyle” Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall TRACH KIT W/HYDROGEN & SALI Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Dover” 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereCalifornia, Florida and Illinois
- Medical device recall Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereCalifornia, Florida and Illinois
- Medical device recall Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereCalifornia, Florida and Illinois
- Medical device recall Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 28, 2024ClassClass IStatusOngoingWhereCalifornia, Florida and Illinois
- Medical device recall IonoStar Plus Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereIowa, New York, Pennsylvania and Washington
- Medical device recall Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereIowa, New York, Pennsylvania and Washington
- Medical device recall Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component… Framegrabber card may not perform as intended. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of… Framegrabber card may not perform as intended. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Indiana, Nevada, Pennsylvania and Texas named
- Medical device recall HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Indiana, Nevada, Pennsylvania and Texas named
- Medical device recall PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Indiana, Nevada, Pennsylvania and Texas named
- Medical device recall Epidural tray Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the… Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Epidural tray Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with… Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component… Disk Bay may not perform as intended. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of… Disk Bay may not perform as intended. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an… VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereCalifornia and Louisiana
- Medical device recall The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to… VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereCalifornia and Louisiana
- Medical device recall Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory… Dual In-Line Memory Modules (DIMMs) may not perform as intended. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ESG PK CUTTING FORCEPS, 5MM, 33CM The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall W&H Surgical handpiece S-12 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3M Specialty Blade Assembly 3M has added the following cautionary statement regarding the use of the product: “Caution - To reduce the risk of burns, which if not avoided may result in… Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Specialty Blade Assembly 3M has added the following cautionary statement regarding the use of the product: “Caution - To reduce the risk of burns, which if not avoided may result in… Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0 The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Synapse CV 6 The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally… Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally… Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally… Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and New York, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Class IIFDA’s classFeb 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia named
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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