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 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30” P-12 Cutting SV426, UDI:… The surgical suture is non-sterile. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30” CV-25 Taper CV3110, UDI:… The surgical suture is non-sterile. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30” P-14 Cutting SV935, UDI:… The surgical suture is non-sterile. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30” C-13 Cutting SV2298, UDI:… The surgical suture is non-sterile. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management… Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, New York and Ohio named
- Medical device recall KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named
- Medical device recall Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All… The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a)… Lack of sterility assurance of the 30-0171 Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report23 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Minnesota, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report23 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Minnesota, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Indiana, Kansas, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, Virginia and Washington
- Medical device recall RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Indiana, Kansas, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, Virginia and Washington
- Medical device recall ProxiDiagnost N90 Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces Test results revealed that the KN95 masks failed to filter greater than 95% of particulates. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM… Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative… FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Indiana, New Jersey and Texas named
- Medical device recall VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator Blood collection tubes experienced an issue with separation and clotting Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Missouri, New York, Pennsylvania and Virginia named
- Medical device recall UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 -… The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida and New Jersey named
- Medical device recall Alere iScreen Single Drug Detection (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere iScreen Multi Drug Detection (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere iCup Drug Detection (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLIA Waived Rapid Drug Test (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Consult Diagnostics Drugs Abuse Test Cup (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Henry Schein One Step + DOA Cup (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ImmuTest Drugs of Abuse Cup (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroScreen (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroTox (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Noble 1 Step+ Cup (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iCup Dx14 Drug Screen Cup(AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oratect III Oral Fluid Drug Screen Device (AMT XXX Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProScreen” Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ “ProScreen” Drugs of Abuse Test… Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ “QuickTox¿ Drug Screen Dipcard 11 Drug… Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /“TDDA Drugs of Abuse Cup… Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ToxCup Drug Screen Cup (AMT Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Check 1 Panel Drug Cup: (THC) Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Check 14 Panel Drug Cup: (BMC style) Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Check 2 Panel Drug Cup: (THC/COC) Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC) Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC) Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drug Screening Component: Uncut Sheets Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels… Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AC/DC POWER SUPPLY for 7400 The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AC/DC POWER SUPPLY for 7400 The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Control, Calibrator Verified, Triage BNP Product was shipped with refrigeration (ice) instead of frozen (dry ice). Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereArkansas, Arizona, Colorado, Florida, Maryland, Michigan, Mississippi, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, Rhode Island and Texas
- Medical device recall Pacific Xtreme (PTCA Balloon Dilation Catheter) Labeling discrepancy for the Rated Burst Pressure (RBP) value. Class IIFDA’s classOct 7, 2020in FDA’s Enforcement Report41 statesnamed in where it went PublishedOct 7, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROFEMUR Neck Long Titanium MicroPort Orthopedics Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 30, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall PROFEMUR Neck Extra Long Titanium MicroPort Orthopedics Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 30, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 -… The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. Class IIFDA’s classSep 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedSep 30, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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