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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility… There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro… There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Neurovascular embolization device Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement Report28 statesnamed in where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Maine, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin
- Medical device recall The Prestige Coil System is a product family of embolic coils with associated delivery system components Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement Report28 statesnamed in where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Maine, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin
- Medical device recall Bubble Sensor (REF: 70105.5720) The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the… Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Minnesota, Nebraska, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Spectral CT on Rails: Software Version 5.1.0.X A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Texas and West Virginia named
- Medical device recall Spectral CT 7500: Software Version 5.0 A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. Class IIFDA’s classFeb 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 14, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Texas and West Virginia named
- Medical device recall EVair air compressor GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall EVair 03 (Jun-air) air compressor GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack,… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR &… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK,… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit… During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27 During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic… There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion system, Interventional fluoroscopic x-ray system System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583]… Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia, Indiana, Michigan, Montana, New York, Pennsylvania, Texas and Virginia 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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