Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3” X 4 YDS) Product Number:D4-324SCP Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit- COBAN¿, LF Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-FORMULA CAP Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit- PENROSE DRAIN (.75” X 18”) Product Number:D8-9425B Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-TUBING W Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the… Product was released to market without the adulteration strip included in the product. Class IIIFDA’s classOct 31, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 31, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medical device recall O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report45 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS Coil overheating can occur when the device is used in Mode 2 setup. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Illinois, Indiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Reinforced Dual Lumen Cannula, 13Fr. The catheter failed the endotoxin testing. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas and Utah named
- Medical device recall Thoratec CentriMag Motor Reports of circulatory support system motor stopping. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement Report43 statesnamed in where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Valeris Medical Apollo Medial Suture Anchor The product was mislabeled as containing the incorrect type of suture. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereFlorida, Ohio, Oklahoma and Texas
- Medical device recall Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations. The products manufactured on 5/5/17 may be assembled incorrectly. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall “Free and Total Protein S ELISA Kit” Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700 Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Ambu Aura40 Standard, Reusable Laryngeal Mask Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare MRI Systems, Software Version 11.x The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare MRI Systems, Software Version 12.x The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare MRI Systems, Software Version 15.x or HD 16 The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, 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.”
Your shortlist0 of 4
Add one more to compare.