Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130 The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Generic Name: restor3d MTP Implant Generic Name: MTP Implant Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, North Carolina, Pennsylvania, South Carolina and Texas named
- Medical device recall Generic Name: MiniMed Go App Generic Name: MiniMed Go App A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier… Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Connecticut, Florida, Louisiana, Massachusetts, Maryland, New York, Ohio, Pennsylvania and Texas named
- Medical device recall InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133… Wrong lead or percutaneous extension selected. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030 Wrong lead or percutaneous extension selected. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Xact mole marker for mammography The radiopaque material may detach from the marker. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Minnesota, Missouri, New York, Ohio, Pennsylvania, Puerto Rico, Texas and West Virginia named
- Medical device recall MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101 Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106 Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108 Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as (list truncated) Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU… Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: (list truncated) Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient’s skin. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard ANTERIOR HIP PACK A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona named
- Medical device recall Halyard ANTERIOR HIP PACK A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. Class IIFDA’s classOct 28, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona named
- Medical device recall HemoslL AcuStar HIT-lgG(PF-4) Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 21, 2026ClassClass IStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Washington and West Virginia named
- Medical device recall HemoslL AcuStar HIT-lgG(PF-4) Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 21, 2026ClassClass IStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Washington and West Virginia named
- Medical device recall JenaValve Trilogy Delivery Catheter, Size 23MM Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall JenaValve Trilogy Delivery Catheter, Size 25MM Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington 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.”
Your shortlist0 of 4
Add one more to compare.