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 GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania
- Medical device recall GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania
- Medical device recall PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania
- Medical device recall PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereFlorida, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania
- Medical device recall ICM LNQ22 LINQ II It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 6, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall RAPIDPOINT 500e Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the… Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RAPIDPOINT 500 Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the… Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VariSoft infusion set The Varisoft infusion set is used in conjunction with tandem insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide, and California named
- Medical device recall VariSoft infusion set The Varisoft infusion set is used in conjunction with tandem insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide, and California named
- Medical device recall VariSoft infusion set The Varisoft infusion set is used in conjunction with tandem insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide, and California named
- Medical device recall Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or… Units are labeled as 10cc; however the units have a fill volume of 1cc units. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania, Texas and Washington named
- Medical device recall Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226… It has been found that potential unintended laser activation can occur without foot pedal depression. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, California, Connecticut, Florida, Kentucky, Maine, Michigan, Missouri, Montana, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall IRON assay, Reference Numbers 6K95-41 and 6K95-30 A high recovery of Iron assay has been observed at some customer sites. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity c Iron Reagent, Reference Number 08P3920 A high recovery of Iron assay has been observed at some customer sites. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus,… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Choleodochoscope Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus,… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hysteroscope-For endoscopic diagnosis within the uterus Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hysterovideoscope-For endoscopic diagnosis within the uterus Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hysterofiberscope-For endoscopic diagnosis within the uterus Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tracheal fiberscope-airway management, which includes observation to access airway anatomy,… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tracheal videoscope- For airway management, which includes observation to access airway anatomy,… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon,… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common… Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Alaris Pump infusion sets (Product Name Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 and Wyoming named
- Medical device recall BD gravity sets (Product Name Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 and Wyoming named
- Medical device recall BD Extension Sets (Product Name Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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 and Wyoming named
- Medical device recall Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 -… Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FilmArray TORCH Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the… Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, 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 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall stryker Sage PrimaFit External Urine Management System for the Female Anatomy A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GEM Premier 3000 PAK - pH, pCO2, pO2, Hct Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2… Class IIFDA’s classNov 29, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereMassachusetts, Minnesota and New York
- Medical device recall GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++ Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2… Class IIFDA’s classNov 29, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 29, 2023ClassClass IIStatusOngoingWhereMassachusetts, Minnesota and New York
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.