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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Halyard ANGIO PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately… Error code “50037” occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 PSA assay The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Iris Scissors, Single-Use, Curved, Standard 4.5 Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Colorado, Connecticut, Florida, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2024in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 13, 2024ClassClass IStatusOngoingWhereArizona, California, Florida, Georgia, Missouri, New Jersey, New York, Pennsylvania, Texas, Virginia and Washington
- Medical device recall Cartesion Prime, Digital PET-CT When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Iowa, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, Mississippi, North Carolina, Nevada, Tennessee, Virginia and Wisconsin
- Medical device recall Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery… A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178” difference in the end of the endoscope slot to the end of the tail piece. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc BGEM BUN Test Card Siemens Healthcare Diagnostics Inc. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Americot 20-01S Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). Class IIFDA’s classNov 13, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereCalifornia, Iowa, Illinois, Minnesota, Missouri, New York, Ohio and Virginia
- Medical device recall iotaSOFT Plus Drive Unit Incorrect GTIN number. Class IIIFDA’s classNov 13, 2024in FDA’s Enforcement ReportIowathe one state its words name PublishedNov 13, 2024ClassClass IIIStatusCompletedWhereIowa
- Medical device recall Medtronic DLP Aortic Root Cannula with Flow-Guard There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal Class IIFDA’s classNov 13, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereIllinois, Michigan, New Jersey, New York, Ohio, Tennessee and Wisconsin
- Medical device recall DeRoyal C-SECTION TRACEPACK DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DeRoyal CHILDREN’S GENERAL TRACEPACK DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DeRoyal CHILDREN’S ORTHOPEDIC TRACEPACK, 89-9349-06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DeRoyal CHILDREN’S LAPTRACEPACK, 89-9362.06 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories There is discrepant labeling on the inner and outer packaging of the device. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative… The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Adult Cap-ONE Biteblock Due to products being shipped/distributed to customers after the products expiration date had past. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Idaho, Kentucky, Massachusetts, Missouri, North Carolina, Oregon and Utah named
- Medical device recall intelliPATH Universal HRP Detection Kit Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico and Texas named
- Medical device recall SONIALVISION G4 is a multi-purpose X-ray R/F system X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Montana, North Carolina, Nebraska, New York, Ohio, Tennessee, Texas, Washington and West Virginia named
- Medical device recall The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and… X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Montana, North Carolina, Nebraska, New York, Ohio, Tennessee, Texas, Washington and West Virginia named
- Medical device recall GE Healthcare Centricity Universal Viewer Zero Footprint GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which… Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H Complaints were received regarding needle pull-off and suture degradation. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn HScribe Holter System There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn Vision Express Holter Analysis System There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio) There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Welch Allyn XScribe Cardiac Stress Testing System There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D. The Bipolar assembly contains an oversized Retainer Ring. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VasoView HemoPro Endoscopic Vessel Harvesting System There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2024ClassClass IStatusCompletedWhereNo state named
- Medical device recall Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2024in FDA’s Enforcement Report40 statesnamed in where it went PublishedNov 6, 2024ClassClass IStatusOngoingWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall CADD-Solis Li-ion Rechargeable Battery Packs Damage to the battery pack may have caused a short to a capacitor within the battery pack. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010,… The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Endoscopic Flushing Pump During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LIFEPAK 15 (LP15) Due to an out of tolerance tool being used on monitor/defibrillator systems. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereConnecticut, Georgia, Massachusetts, New York, Ohio, Washington and West Virginia
- Medical device recall ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic… Epoxy used to seal the edge of the transducer into its paddle exceeded specification. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereFlorida, Georgia, New Jersey and Tennessee
- Medical device recall Quest Spectrum 3 Fluorescent Imaging System Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportOhiothe one state its words name PublishedNov 6, 2024ClassClass IIStatusOngoingWhereOhio
- Medical device recall Abbott Alinity m HPV AMP Kit, used with the Alinity m System Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin 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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