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 SW Bari Lift & Transfer Retrospective engineering analysis against current ISO standards for hoists has determined: 1. Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump… Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump… Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee… Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and… Class IIFDA’s classApr 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hemostasis Probe The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A… A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kentucky, Michigan, Missouri, New Mexico, Puerto Rico and Tennessee named
- Medical device recall LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 17, 2024in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 17, 2024ClassClass IStatusOngoingWhereCalifornia, Colorado, Idaho, Michigan, Nebraska, New Jersey, Nevada, Oklahoma, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Altair 330 lbs w/o Hanger Bar Patient lift hanger bar may come loose, which could potentially pose risks to patients. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Oklahoma and Texas named
- Medical device recall Bed Assist Bars, labeled as follows: a) Medline Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConvaTec CarboFlex, 15cm x 20cm, 6 in The product does not meet sterility assurance level. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, New Mexico, Pennsylvania, Texas and Washington named
- Medical device recall ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference… Medical device components were marketed without FDA clearance and without FDA approval Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall ACETABULAR BEARING (xx)MM I.D X (xx) O.D Medical device components were marketed without FDA clearance Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers:… Medical device components were marketed without FDA clearance Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall Chromophare Surgical Light System Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to… Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular… Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereIllinois and New York
- Medical device recall Hillrom Welch Allyn Spot Vision Screener VS100 Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereIllinois and New York
- Medical device recall Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM… Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereIllinois and New York
- Medical device recall EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach… Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach… Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both… Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both… Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach… Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may… Class IIFDA’s classApr 17, 2024in FDA’s Enforcement Report21 statesnamed in where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Florida, Kansas, Kentucky, Maryland, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Mojo Full Face with Headgear, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mojo Non Vented Full Face Mask with Headgear, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mojo 2 Full Face Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mojo 2 Full Face Non Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mojo 2 Full Face AAV Non Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall iQ 2 Nasal Vented Mask Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Phantom 2 Nasal Vented Mask Update to contraindications and warning language due to CPAP masks containing magnets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall X-Guide Handpiece Adaptor Sleeve 1 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall X-Guide Handpiece Adaptor Sleeve 3 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System)… Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System)… Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hill-Rom PRO+ 36” MRS Surface Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass 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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