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 Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CODAN SWAN-LOCK Swabable Needlefree Connector Individual packages of connectors may have incomplete or bad seals which would compromise sterility. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereCalifornia, Michigan, New York, Pennsylvania and Virginia
- Medical device recall Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x… A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, Texas, Virginia and Wisconsin named
- Medical device recall Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, Texas, Virginia and Wisconsin named
- Medical device recall Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, Texas, Virginia and Wisconsin named
- Medical device recall (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Control Panel The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Kentucky, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Control Panel The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Kentucky, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall DIRECT SUPPLY Attendant VITAL SIGNS MONITOR Failures were found in the temperature measurement function while in the predict mode. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois, Louisiana, Massachusetts, Minnesota, Montana, North Carolina, New Hampshire, New York, Ohio, Texas, Utah and West Virginia
- Medical device recall Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/… The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 XXX Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Vein Irrigation Cannula with blunt tip The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Vein Irrigation Cannula with blunt tip The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Isolation Droplet Bundle Kit Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereLouisiana and Missouri
- Medical device recall Respirator Crash Cart Kit Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereLouisiana and Missouri
- Medical device recall ABL80-FLEX-393-839 Box Label Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ABL80-FLEX CO-OX 393-841 Box Label Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are… Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor,… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are… Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor,… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS… Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall uCT 530 Computed Tomography X-Ray System Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 8, 2020ClassClass IIStatusOngoingWhereTexas
- Medical device recall Elekta Unity, Image-Guided Radiation Therapy System There have been reports of excessive heating in the MRL Gradient Connection Module. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereIowa, New York and Pennsylvania
- Medical device recall Flow Coupler Monitor, GEM, Global Excellence Microsurgery A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusOngoingWhereArizona, California, District of Columbia, Florida, Georgia, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New York, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box Natural rubber is present in Hybrid Wraparound Knee Support labeled as “Not made with Natural Rubber latex”. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereArkansas and Ohio
- Medical device recall Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Orthodontic Bracket is mislabeled Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Idaho, Michigan and Texas
- Medical device recall Maestro Orthodontic Bracket REF711-298Q QTY. 20 Orthodontic Bracket is mislabeled Class IIFDA’s classJul 8, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Idaho, Michigan and Texas
- Medical device recall BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or… The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the… Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Georgia, New Jersey, Ohio and Texas 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.