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 Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body The indicator may show available charge when the battery is close to depletion. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Compress, Mini Compress Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COMP RVRS Shoulder Baseplates, including Custom Products Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACROMIUM FLANGE SET (Custom product) Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HENNESSY LEFT CONST GLENOID HA Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Hip systems Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive HHR Tess Cleat Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Comprehensive RS Cleat CAP Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various Custom Products Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Copeland HA Resurfacing Head, MB/HA EAS Head Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BALL NOSE GUIDE WIRE 80CM, 100CM Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.0MM BALL NOSE GUIDE WIRE Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LT DISC ULNA - HA/PC Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOMOD PORCOAT HA GLENTRAY Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FoundationOne CDx test report Identified potential false positive MSI-H on the test reports provided to the physicians. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereGeorgia, Indiana, Massachusetts, North Carolina and Ohio
- Medical device recall Platelet Aggregation Kit Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain… Class IIIFDA’s classDec 4, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 4, 2019ClassClass IIIStatusOngoingWhereArizona, Georgia, Louisiana, Massachusetts, Maine, New York, Ohio, Tennessee, Texas and West Virginia
- Medical device recall Collagen Reagent Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain… Class IIIFDA’s classDec 4, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 4, 2019ClassClass IIIStatusOngoingWhereArizona, Georgia, Louisiana, Massachusetts, Maine, New York, Ohio, Tennessee, Texas and West Virginia
- Medical device recall myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management… The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereGeorgia, Illinois and Texas
- Medical device recall Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedDec 4, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedDec 4, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedDec 4, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Intersomatic JULIET Ti OL cage Inner blister pack label is incorrect and does not match the correct external box label. Class IIIFDA’s classDec 4, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 4, 2019ClassClass IIIStatusTerminatedWhereCalifornia
- Medical device recall V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 4, 2019ClassClass IIStatusOngoingWhereNew York
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SWANSON GREAT TOE, TITANIUM SZ 4 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PRO-STIM 10cc INJECTABLE The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INBONE STEM, TIBIAL, TOP The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VALOR SCREW 5.0MM X 45MM LEN The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dart Fire HEADED SCREW 4.0X 32MM The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Darco STERILE HEADED DRILL BIT 4.4MM The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EVANS OPENING WEDGE PLATE 10MM The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SWANSON FINGER JOINT #1 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state 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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