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 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall PriMatrix Fenestrated Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PriMatrix Meshed Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PriMatrix Ag Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PriMatrix Ag Fenestrated Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PriMatrix Ag Meshed Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm. Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm. Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom medical procedure packs labeled as: a) OPEN HEART TRACECART The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aptio Automation Storage and Retrieval Module (SRM) A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall NexGen Precoat Stemmed Tibial Plate Size 5 Device outer packaging was incorrectly labeled. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal,… Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT… Class IIIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 12, 2023ClassClass IIIStatusOngoingWhereNationwide, and Florida, Michigan, New Mexico, New York, Tennessee and Texas named
- Medical device recall BD Pyxis CII Safe, Software: V7 Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Pilling O’REILLY ESOPHAGEAL RETRACTOR There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pilling LOWSLEY PROSTATIC TRACTOR CVD There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pilling LOWSLEY PROSTATIC TRACTOR STR There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KLS Martin Battery Pack Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 12, 2023ClassClass IIStatusOngoingWhereFlorida
- Medical device recall BD Synapsys Informatics Solution There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereCalifornia, Colorado, Iowa, Illinois, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah and Wisconsin
- Medical device recall Giraffe OmniBed Carestation CS1 GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW)… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Giraffe OmniBed, with the following GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW)… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Beside panel FRU (Field Replacement Units) Kits GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW)… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Stryker Infinity Alignment Frame Distal Sub-Assembly The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Trilogy Evo, Evo Clinical Korean There are errors present in the Korean Instructions For Use where the word “invasive,” was incorrectly translated to “noninvasive”. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 5, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico 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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