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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Abbott Alinity m STI AMP Kit, used with the Alinity m System Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall MICR PATIE RND Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/4X1-1/2 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/4X3 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/4X1/4 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/2X1/2 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 3/4X3/4 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/2X1 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1X1 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/2X1-1/2 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/2X2 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1/2X3 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 1X3 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG PAT XRAY 3X3 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 1/8X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 1/4X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 1/2X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 3/4X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 1X6-200 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 1-1/2X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 2X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 3X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall SURG STRP 3-1/2X6 Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm… Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic… The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control… Class IIIFDA’s classNov 6, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 6, 2024ClassClass IIIStatusOngoingWhereArizona, California and New Hampshire
- Medical device recall Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin… This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 6, 2024ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Product Name: Insight Base Flex - 8 The patient label stickers may have the wrong expiration date recorded. Class IIIFDA’s classNov 6, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 6, 2024ClassClass IIIStatusOngoingWhereFlorida, North Carolina, New York, Pennsylvania and Virginia
- Medical device recall Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000),… Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Duraform Dural Graft Implant, Size 3x3 Out of specification endotoxin levels. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 1) Flex Extenders, 5.2” x 15mm OD x 15mm ID Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlaska, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington and West Virginia
- Medical device recall Olympus Electrosurgical Generator There was an increase in complaints indicating an occurrence of system error E1226 “Could not write to Audio Buffer” during procedures using the ESG-410 (SEP). Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Access Thyroglobulin Antibody II IFUs for the device incorrectly states the biotin interference was remediated. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall remel BactiDrop Acridine Orange A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereIllinois, Indiana, Minnesota, Nebraska, South Dakota, Texas, Virginia and Washington
- Medical device recall Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, Oklahoma, Pennsylvania, South Carolina, Texas, Vermont, Washington and Wisconsin
- Medical device recall Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, Oklahoma, Pennsylvania, South Carolina, Texas, Vermont, Washington and Wisconsin
- Medical device recall AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to… Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 6, 2024ClassClass IIStatusOngoingWhereTexas
- Medical device recall smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 6, 2024ClassClass IIStatusOngoingWhereTexas
- Medical device recall AVOXimeter 1000E, Product Number: AVOX1000E Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportArizonathe one state its words name PublishedNov 6, 2024ClassClass IIStatusCompletedWhereArizona
- Medical device recall KLS Martin Battery Pack The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 6, 2024ClassClass IIStatusOngoingWhereFlorida
- Medical device recall smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlabama, California, Delaware, Georgia, Mississippi, North Carolina and Tennessee
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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