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 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Guidewire 70cm x 1mm Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio, Texas and West Virginia named
- Medical device recall Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Mississippi, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Texas and Virginia named
- Medical device recall ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Mississippi, New Jersey, Nevada, New York, Pennsylvania, Puerto Rico, Texas and Virginia named
- Medical device recall Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Due to a manufacturing issue, red particulates present in the expressed composite. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Due to a manufacturing issue, red particulates present in the expressed composite. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Due to a manufacturing issue, red particulates present in the expressed composite. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall CRANIOTOMY PACK, Pack Number DYNJ46552O A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois and Texas
- Medical device recall KIT PEDI CRANI LAMI, Pack Number DYNJ907372A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois and Texas
- Medical device recall ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois and Texas
- Medical device recall ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois and Texas
- Medical device recall Medtronic Handset with Communicator A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8’’ Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle… Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space) Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the… Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN,… There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes,… There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes,… There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10… Safety Parameters Verification Mechanisms can be deactivated in clinical runtime Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Florida, Illinois, Louisiana, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm… Potential for an incomplete seal on the packaging tray. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37… Potential for an incomplete seal on the packaging tray. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm… Potential for an incomplete seal on the packaging tray. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv Potential for an incomplete seal on the packaging tray. Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ROTATION MEDICAL TENDON STAPLES Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ROTATION MEDICAL TENDON STAPLES Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility Class IIFDA’s classSep 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 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.”
Your shortlist0 of 4
Add one more to compare.