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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Genius 3 Tympanic Thermometer- electric thermometer The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Genius 2 Tympanic Thermometer OEM Tympanic The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Genius 2 Tympanic Thermometer OEM Tympanic The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Genius 2 Tympanic Thermometer Private Label The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GORE¿ EXCLUDER¿ AAA Endoprosthesis Firm has received reports of leading end catheter component separations. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) Firm has received reports of leading end catheter component separations. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length The lot contained two outer pins instead of one outer and one inner pin. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereCalifornia and Ohio
- Medical device recall Medonic M-Series Hematology Analyzer M16S BD ABR US A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AAMI 3 FABRIC REINFORCEDGown 2XL NS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURG GOWN 2XL BNS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABREINF SURG GOWN L NS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 ROYALSILK SURGGOWN BNS L, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 ROYALSILK SURGGOWN BNS XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 ROYALSILK SURGGOWN BNS 2XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall ROYALSILK 3XLARGE/XLONG NS, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-RNF SURG GOWN 3XL LONG The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREIN SCRBNURGOWN BNS L The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRIC REINF SURG GOWN XL NS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREIN SURG GOWN L BNS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREIN SURGGOWN BNS XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONRNF SURG GWN 2XL XLNG BNS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREINF SURG GOWN 3XL BNS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall ROYALSILK LARGE, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall ROYALSILK 2XLARGE, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall ROYALSILK 3XLARGE/XLONG, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRIC REINF SURG GOWN XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRIC REINF SURG GOWN 2XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall ROYALSILK XLARGE, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURGICAL GOWN XXL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREINF SURG GOWN 2XL XLONG The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NONREINF SURGICAL GOWN 4XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall GOWN SURG LG W/TOWEL ST BACK The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURGICAL GOWN XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRNF SURG GOWN L 2 TOWELS The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURG GOWN LG 2 TWL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico 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.”
Your shortlist0 of 4
Add one more to compare.