Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Medline Convenience kits used for various procedures: 1) CW PERI GYN There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) STANDARD D&C There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) PERI GYN PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) BASIC CATARACT There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Guide Wire with Ruler Tube 3x800 mm DIA The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas and West Virginia named
- Medical device recall Guide Wire with Ruler Tube 3x1000 mm DIA The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas and West Virginia named
- Medical device recall Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S… Medline medical procedure kits, containing Medtronic Aortic Root Cannula FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 16, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas and West Virginia
- Medical device recall Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 16, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas and West Virginia
- Medical device recall Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN… Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 16, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas and West Virginia
- Medical device recall Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT… Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 16, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas and West Virginia
- Medical device recall Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 16, 2025ClassClass IStatusOngoingWhereCalifornia
- Medical device recall Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 16, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 16, 2025ClassClass IStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin
- Medical device recall FilmArra Pneumonia Panel plus (Pneumoplus) Increased risk of control failures and false negative test results with multiplexed nucleic acid test. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DxI 9000 Access Immunoassay Analyzer Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Wayson Hydrocolloid Models: 1) There is a potential for the sterility of the device to be compromised. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT There is a potential for the sterility of the device to be compromised. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IVX Station Reconstitution Transfer Set IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportAlabamathe one state its words name PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlabama
- Medical device recall stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Glenoid Digitizer Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Coracoid Clamp Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Instrument Check Block Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Box Base Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Glenoid Box Lid Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Depth Stop Pin Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker Blueprint Mixed Reality Instrument Kit Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall stryker HoloBlueprint Application Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee and Texas
- Medical device recall Stimulation RC Clinician Programmer Application There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GenetiSure Dx Labeling Kit DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedApr 16, 2025ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall BD Pyxis” MedBank” Mini and BD Pyxis” MedBank” Tower, BD Pyxis” MedFlex, BD Pyxis” MedBank” MedPass are… Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue) Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue) Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P /… Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message “Stocking window has passed, or… Class IIFDA’s classApr 16, 2025in FDA’s Enforcement Report32 statesnamed in where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Atellica CH Revised C Reactive Protein (RCRP) Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otopore Cylinder Standard outer ear dressings There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore Standard 4cm fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore Standard 8cm fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otopore Cylinder outer ear wound dressing, Firm There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore 8cm fragmentable nasal dressing, Firm There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore 4cm fragmentable nasal dressing, Firm There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Otopore Square outer ear wound dressing, Firm There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nasopore FD fragmentable nasal dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hemopore 8cm nasal/sinus temporary wound dressing There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. Class IIFDA’s classApr 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 9, 2025ClassClass 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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