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 7, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall R&D CBC-3D Hematology Control For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 25, 2023ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Kentucky, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Puerto Rico and Texas named
- Medical device recall AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF There is potential for the footrest to detach from the patient table during use. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall AXIOM Luminos Agile There is potential for the footrest to detach from the patient table during use. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max There is potential for the footrest to detach from the patient table during use. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229 Complaints of leaking packets were received. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 18, 2023in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 18, 2023ClassClass IStatusTerminatedWhereVirginia
- Medical device recall MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 18, 2023ClassClass IStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Philips Trilogy 100 Ventilator The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips Trilogy 200 Ventilator The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips Garbin Ventilator The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay… Internal comparison studies revealed unacceptable, light staining. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Codman Surgical Patties Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and West Virginia named
- Medical device recall Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Black specks may be present on the packaged needles Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, Indiana, Minnesota, New York, Ohio, Texas and Virginia named
- Medical device recall Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 6.5 cm Adult Rotating Craniotome Attachment Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 6.5 cm Adult Craniotome, Thin Foot Plate Attachment Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Adult Craniotome Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 6.5 cm Adult Rotating Craniotome Attachment Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Adult Craniotome, Large Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 7.5 cm Large Rotating Craniotome Attachment Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 6.5 cm Pediatric Craniotome Attachment Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pediatric Craniotome Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment,… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prep-Fill Guarded Luer Connector (GLC): a Blister package had an unsealed edge compromising sterility. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall DeRoyal ORGAN RECOVERY PACK PGYBK, a) DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Missouri named
- Medical device recall BD Pyxis MedBank System - Product Label/labeling pending Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Medline CISION Sterile Blades Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall PHS Lacertaion Tray, Sterile, 20 per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Henry Shein CYSTO SET UP PACK, 20 per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Henry Shein GLOVES Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall PICC KIT, 10/CS, ACCESS MEDICAL LABEL Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT 500mL BAGS, 2 Port, Sterile, Triple Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT CENTRAL LINE Insertion Tray, I2 per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall HCT MAX BARRIER PICC INSERTION TRAY 12 per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall McCormick Medical Distribution PORT TRAY, 25 trays per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Stradis Healthcare TCTR Convenience Kit Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20 Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas 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.”
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