Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Omega Medical Imaging Elevating Monitor Suspension Systems An actuator separated from the pivot mechanism on a lower monitor boom system column. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereAlabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio and Oklahoma
- Medical device recall Grafton DBM Crunch Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton DBM (Flex) Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton DMB Matrix Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton DBM Matrix Strips Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton DBM Orthoblend Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton Plus DBM Paste Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Grafton DBM Putty Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall General Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall LAVH, REF BBLV21C During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Breast Plastics Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Robotics Pack SAH During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall CVS PCSU SJH During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Pediatric Heart SJH During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Vasc. Open CVOR SJH, REF SJVO56B During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Robotics Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Robotics Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Sub Q Recorder Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Pediatric Urology Wolson Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall Cath Cardiac Pack During an internal investigation, ACS identified that the components, I.V. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Iowa named
- Medical device recall OPMI LUMERA 300 Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the… Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 1, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Louisiana, Maryland and Texas named
- Medical device recall Olympus High-Flow Insufflation Unit There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and… Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Syringe contains conical tip that is not compatible with certain needleless IV connector(s). Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Illinois, Massachusetts, Minnesota, North Carolina, Oregon, Rhode Island, South Carolina and Tennessee
- Medical device recall HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following… Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois and Texas named
- Medical device recall HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following… Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois and Texas named
- Medical device recall DeRoyal Head and Neck procedure kit DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedOct 25, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SenSight Connector Plug Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed… Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Functional MR V1.0 When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance… Class IIFDA’s classOct 25, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereMassachusetts and Michigan
- Medical device recall Gladiator, Wrist & Thumb Orthosis The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereCalifornia, North Carolina and Wisconsin
- Medical device recall 10ML SYRINGE LUER LOCK W/OUT NEEDLE There is a potential for blood backfill leakage and foreign material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 10ML SYRINGE LUER LOCK W/NEEDLE There is a potential for blood backfill leakage and foreign material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 3ML Syringe Luer Lock with needle 20GX1 There is a potential for blood backfill leakage and foreign material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T Hemodialysis SYS, with CDX Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T Hemodialysis System without CDX Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T Hemodialysis System w/Bibag Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T GEN 2 Bibag without CDX Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T HD SYS Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T HD SYS Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T HD SYS Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 2008T HD SYS Potential PCBA leaching from tubing of hemodialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall 3T Heater Cooler System The firm’s labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Indiana, Minnesota, North Carolina, New Jersey, South Carolina and Texas named
- Medical device recall Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the… Device is breaking while in use, potential for patients to require a revision surgery. Class IIFDA’s classOct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass 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.