Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere” hCG Combo Cassette The firm initiated recall of Alere” hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional… Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Illinois, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare… Internal investigation demonstrated under-recovery for glucose when tested against a reference method. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Canon Full Auto Ref-Keratometer RK-F2 Canon Inc. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard… AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber… AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Natus neurology Dantec KEYPOINT.NET 2.20 Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed… Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Mississippi, Nevada, Texas and Wisconsin named
- Medical device recall RayStation Therapy Treatment Planning System Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereConnecticut, Florida, Massachusetts, Missouri, New York and Ohio
- Medical device recall Leucadia Autolok” Polyaxial Pedicle Screw System Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia” Autolok set screw may… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL DrySlide PYR Kit In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL DrySlide Oxidase Kit In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000 Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in… Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thyroidectomy Indication for the da Vinci Surgical Systems Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k). Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cannula 8MM Regular Clarification of existing labeling information and operating procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. Clarification of existing labeling information and operating procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci Si Surgeon Console Clarification of existing labeling information and operating procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum,… Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Kentucky, Michigan, Mississippi, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Kentucky, Michigan, Mississippi, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Kentucky, Michigan, Mississippi, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/… On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereAlabama, Georgia, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Texas, Virginia and Vermont
- Medical device recall Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible… On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereAlabama, Georgia, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Texas, Virginia and Vermont
- Medical device recall Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure) Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental… The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MyRay RXDC dental unit x-ray unit The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Class IIFDA’s classMay 29, 2013in FDA’s Enforcement Report22 statesnamed in where it went PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall VITROS Immunodiagnostic Products CK-MB Calibrators Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid… Class IIIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brilliance CT 16-Slice Water, System Code: 728245 Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, 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, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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