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 TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole Modifications to the specification were not appropriately qualified through the company’s design control process which may result in structural integrity… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Texas and Washington
- Medical device recall Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400 Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report40 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the… A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis… A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter -… Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter -… Potential for leaking product Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Massachusetts and Pennsylvania named
- Medical device recall ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform The incorrect device was packaged in the vial. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Maryland, New Mexico, Nevada, New York, Pennsylvania and Texas
- Medical device recall Vista Dental Products CanalClean Endodontic Irrigation Kit The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12 The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8 The affected lots may be packaged in syringes which include an incorrect bung. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ImplantDirect Legacy 3 Implant Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Hawaii, Idaho, Kansas, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee and Utah named
- Medical device recall Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Massachusetts, Maryland, Missouri, Montana, New Jersey, New Mexico, New York, Ohio, South Carolina and Virginia
- Medical device recall C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is… Stryker C2 NerveMonitor’s design and instructions may not optimally address usability issues related to the functionality of the device, which may result in… Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is… Stryker C2 NerveMonitor’s design and instructions may not optimally address usability issues related to the functionality of the device, which may result in… Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall Custom Procedure Kit, Vein Kit Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereIllinois and Virginia
- Medical device recall Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes -… The metal cannula are potentially too loose and may become loose when applying the filing material. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereIowa and New York
- Medical device recall Embryology Heated Plate within the RI Witness The touchpad may not work properly after cleaning. Class IIIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 9, 2019ClassClass IIIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Georgia, Illinois, Michigan, North Carolina, New Jersey, Pennsylvania and Washington named
- Medical device recall L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Delaware, Florida, Georgia, Maryland, North Carolina, Nevada, Pennsylvania, South Carolina, Texas, Virginia and Washington
- Medical device recall TxRx 15Ch Knee Coil 3T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx 15CH Knee Coil 1.5T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx CP Extremity Coil 3T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx 15CH Knee Coil 1.5T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx 15CH Knee Coil 3T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx Knee 15 Coil 1.5T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall TxRx Knee 15 Coil 1.5T QED Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo 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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