Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8” & 1/2 flare with… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8” flare Product Usage: The Aortic Cannula… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2” & 3/8” flare or connector Product Usage:… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Venoatrial Cannulae 36/46 Fr with 1/2” flare or connector Product Usage: The Aortic Cannula is… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2” flare or… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip,… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8” flare, 30 Fr with 3/8” connector and 30 Fr with… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary… During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 30, 2014ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient… The temperature probe does not properly connect to the temperature port. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece) The temperature probe does not properly connect to the temperature port. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall QLAB 10 Core Module PN 453561704771 The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Iowa, Kentucky, Maryland, New York, Pennsylvania, Utah, Virginia, Washington and Wisconsin
- Medical device recall QLAB 10.1 Core Module PN 453561728001 The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Iowa, Kentucky, Maryland, New York, Pennsylvania, Utah, Virginia, Washington and Wisconsin
- Medical device recall Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication… Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. Product was distributed without 510(k) approval. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Healthcare, CARESCAPE Monitor B650 Possible sound loss associated with the CARESCAPE Monitor B650. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P) A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video… Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile… During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. Class IIIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall e.cam camera system Siemens Medical Solutions USA, Inc. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 23, 2014ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Symbia E camera system Siemens Medical Solutions USA, Inc. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 23, 2014ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Kentucky, Massachusetts, Maryland, New Jersey, New York and Rhode Island named
- Medical device recall SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Sterility of device is compromised due to breach in sterile barrier Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Sterility of device is compromised due to breach in sterile barrier Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Sterility of device is compromised due to breach in sterile barrier Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Sterility of device is compromised due to breach in sterile barrier Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SUTUREFIX Ultra S Double Loaded Suture Sterility of device is compromised due to breach in sterile barrier Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Dental Tapered Screw-Vent Implant Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a… Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Shape HF Cardiopulmonary System Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI… Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which… During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which… During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom… During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems… During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems… During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Thermo Scientific VersaTREK REDOX 1 Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereColorado, Illinois, Indiana, Nebraska, New Jersey, Pennsylvania, South Dakota and Virginia
- Medical device recall Coat-A-Count Direct Androstenedione, SMN 10381049 The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Michigan, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall V-Series Patient Monitoring System ECG interpretation feature issues. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereLouisiana, Montana, New Jersey, South Carolina and Wyoming
- Medical device recall ACL TOP (Base), automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP 700, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP 700 LAS, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP 500 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP 700 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ACL TOP 300 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, 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.