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 Q-Stress/XScribe Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various… Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Portex Lumbar Puncture Tray Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Massachusetts, Maryland and Missouri named
- Medical device recall Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx,… Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIStatusCompletedWhereNationwide
- Medical device recall CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Louisiana, Maryland, Minnesota, Missouri, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Velofix SA cervical cage The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, North Carolina, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is… The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 6, 2020ClassClass IIStatusOngoingWhereNationwide, and Iowa, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall Leksell Vantage Stereotactic System A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Massachusetts, Minnesota, Montana, North Carolina, New Hampshire, New York, Ohio and Utah named
- Medical device recall CapsoCAM Plus, UDI: 00867770000209 Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the… Class IIFDA’s classMay 6, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Hawaii, Louisiana, New Jersey, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator’s Manual regarding the proper use of connectors with the Prismaflex system. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2020ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall VITROS Immunodiagnostic Products TT4 Reagent Pack The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. Class IIIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ICU Medical Cogent Hemodynamic Monitoring System, Cogent Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 6, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Maryland, North Carolina, Nebraska, New York, Vermont, Washington and Wisconsin named
- Medical device recall ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Through internal investigation is has been determined that an incorrect component was used within the power supply. Class IIFDA’s classMay 6, 2020in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 6, 2020ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall ARCHITECT HAVAB G Reagent Kit An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050… An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single… An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090… An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100… An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021) An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter Power Express Sample Processing System AU5800XL connection unit Potential exposure to biohazard. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report23 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas and Washington
- Medical device recall The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical… There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Fentanyl Reagent Kit, Product N Labeled for diagnostic use and sold to clinical labs without a 510(k). Class IIFDA’s classApr 29, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, North Carolina, New Hampshire, New Jersey, New York and Texas
- Medical device recall ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses Package integrity failure observed during routine shift package integrity testing at an external re-packager. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HEMO-7 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HEMO-10 Hemospray Endoscopic Hemostat Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 2008T Hemodialysis Machine A “Remove USB Device 2” false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fresenius 2008T BlueStar Hemodialysis Machine A “Remove USB Device 2” false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Kansas, Massachusetts, Maryland, Michigan, Missouri, New Hampshire, New Jersey and Pennsylvania named
- Medical device recall Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250) Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON… Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall RaySert PLUS RSP01 RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Idaho, Indiana, Maryland, Minnesota, New Jersey, Ohio, Puerto Rico and South Carolina named
- Medical device recall KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on… If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TCM4 Base unit Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Indiana, Kansas, Massachusetts, Minnesota, North Dakota, New York, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing… Class IIFDA’s classApr 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2020ClassClass IIStatusOngoingWhereNationwide
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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