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 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 3600 Immunodiagnostic System - Refurbished Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Integrated System Software Versions 3.3.3 and below Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pediatric Adjustable Flange Tracheostomy Tube Cuffless One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereMississippi, Nebraska, Tennessee and Texas
- Medical device recall PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation… An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Georgia, Illinois, Indiana, Missouri, New Mexico, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia and Vermont named
- Medical device recall Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MEVION S250i, MEVION S250 Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Missouri, New Jersey, Ohio and Oklahoma
- Medical device recall Utak NR Trace Elements Serum Control, 5 ml The product has an incorrect reference value for cadmium and an incorrect expected range. Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005… The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Michigan, Minnesota, Missouri, Nebraska, New York and Texas named
- Medical device recall HYGENIC Dental Dam Forceps Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HYGENIC Simple Dam Kit Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HYGENIC Winged Fiesta Kit Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HYGENIC Wingless Fiesta Kit Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall AIA-900 Analyzer The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I… The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Kansas, Missouri, North Carolina, New Jersey, Ohio, Oklahoma, Puerto Rico, Virginia, Washington and Wisconsin named
- Medical device recall RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all… It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP Incorrect product labeling. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kansas, Maryland, New York, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy,… There may be dimensional manufacturing error that represents a potential safety risk to patients. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Indiana, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon and Texas named
- Medical device recall Oscar 2, Model 250 System The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Louisiana, Maryland, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Utah named
- Medical device recall ADVIA Chemistry Calibrator Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH Chemistry Calibrator Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179… Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RP500e Handheld Barcode Scanner, Zebra The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Giraffe OmniBed with installed Servo Oxygen module Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Giraffe Incubator with installed Servo Oxygen module Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Piccolo Xpress chemistry analyzer Incorrect reference ranges of analytes. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kentucky, Oklahoma, Pennsylvania, Texas and Virginia
- Medical device recall Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Device and tray that houses the device did not pass steam sterilization process validation testing Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Device and tray that houses the device did not pass steam sterilization process validation testing Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Product Performance Verifier I Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Product Performance Verifier II Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on… Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to… There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri and North Carolina named
- Medical device recall Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be… There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri and North Carolina named
- Medical device recall Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal… Incorrect expiration date Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Hawaii, Kansas, Maryland, New Jersey, Nevada and Puerto Rico named
- Medical device recall PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker Locking Screw, Fully Threaded S2 05x35 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 Compression Screw, Advanced T2 Tibia 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 T2 Tibia +10 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, Standard T2 Humerus ¿6 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 1 End Cap T2 Humerus ¿6mm, 5mm height 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 T2 Humerus ¿6mm, 15mm height 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, Partially Threaded T2 Tibia ¿5x55 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
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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