Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker End Cap, Std, Ti Gamma3 Seal integrity of the blister pack may be compromised and sterility cannot be assured Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAMMOMAT Revelation If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm’s manual movement… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium… Product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium… Product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium… Product may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall DDU-2300 Lifeline/ReviveR View A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are… A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DDU-2450 Lifeline ECG A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the… Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction… Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral… Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term… Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica ARveo and M530 OH6 microscope systems. Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades. Becton Dickinson and Company, is conducting a voluntary recall on the V. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kentucky and Virginia named
- Medical device recall Alinity C, Processing Module There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Georgia, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS Incorrect labeling of dialysate concentration for hemodialysis. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes… The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 17, 2020ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Ovation iX Abdominal Stent Graft Systems A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 17, 2020ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Missouri and Oklahoma named
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon GENILook There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall Genicon Natura There is potential for the plastic optical tip to become detached from the metal shaft. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 17, 2020ClassClass IIStatusOngoingWhereAlabama, Delaware, Florida, Georgia, Missouri, North Carolina and Tennessee
- Medical device recall ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 -… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage:… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product… The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient… Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Ormco Damon Q2 Orthodontic Metal Bracket The bracket torque was mislabeled on the packaging. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Florida, Georgia, Illinois, Louisiana, Mississippi, North Carolina, Nebraska, New Jersey, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert… Incorrect IOL diopter Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Iowa, Michigan, Nebraska, Pennsylvania and Texas 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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