Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall PROX LAT HUMERAL LOCK PLATE Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Periarticular locking plate elbow-sterile Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Hip Joint Replacement Systems Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLS Brevius Stem Kinectiv, hip prosthesis, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fitmore Hip Stem, hip prosthesis, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Knee Systems for knee joint arthroplasty, knee prosthesis Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Surgical Instruments: Screws and Reamers Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Devices for Limb salvage arthroplasty Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LPS-MOB ART SURF IMPL D 9MM Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Knee Systems Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various fixation systems and accessories Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CABLE-READY SHORT GTR and CABLE-READY LONG GTR Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various fixation systems and accessories Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various temporary devices used during the implantation of the device system: bone fixation plates and screws,… Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Connection Screw for NCB Plate Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB Straight Narrow Plate, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NCB-PH Plate with 4/5/7 Lock Holes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FEMOROTIBIAL/FEMORAL NAIL, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul Taper Liner, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul Femoral Heads, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ceramic Femoral Heads, various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cephalomedullary Nail (CMN), Various sizes Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grab n Go Opti series VIPR system Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Grab n Go Opti series VIPR system Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Grab n Go Opti series VIPR system Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Grab n Go Opti series VIPR system Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Grab n Go Opti series VIPR system Limited access to flow settings as a result of the control knob having been rotated beyond its functional range Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955 Sterile packaging incomplete seals may compromise sterility of the product Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall lmpella CP with Smart Assist This one pump shipped with incorrect pump programming, the initial production working version of the program. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS… Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report50 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusOngoingWhereAlaska, 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 Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Omnipod DASH Insulin Management System, Product There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB),… Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Posey Connected Twice-As-Tough Cuffs Not meeting design specifications. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report32 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlaska, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall DEMO No Needle Corrugated Carton 20 U/D There is a potential for “No Needle Demo Units” to contain a needle. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DEMO No Needle Corrugated Carton 30 U/D There is a potential for “No Needle Demo Units” to contain a needle. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DEMO No Needle Corrugated Carton 40 U/D There is a potential for “No Needle Demo Units” to contain a needle. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DEMO No Needle Corrugated Carton 20 U/D There is a potential for “No Needle Demo Units” to contain a needle. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DEMO No Needle Corrugated Carton 30 U/D There is a potential for “No Needle Demo Units” to contain a needle. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft The staplers may contain an out of specification anvil component within the jaw of the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft The staplers may contain an out of specification anvil component within the jaw of the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft The staplers may contain an out of specification anvil component within the jaw of the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft The staplers may contain an out of specification anvil component within the jaw of the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Model No. 01-1501-0032 (Child Nail Attachment Bolt) Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt) Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall SORIN Heater-Cooler System 3T 120V~/60Hz The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CentriMag Acute Circulatory Support System Motor, U.S Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall C3 Wave App, v. 2.0.5 When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Louisiana, Massachusetts, Maine, North Carolina, Ohio, Tennessee, Virginia and West Virginia
- Medical device recall Synapse System 3.5mm TI Cancellous Polyaxial Screws The subject product measures 4.0mm in diameter instead of 3.5mm. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNew Jersey
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.