Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall IDS-iSYS Intact PINP It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall IDS-iSYS Intact PINP Control Set It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall Access Folate Calibrators Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access Folate WHO Calibrators Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens syngo.plaza radiological image processing system. Siemens became aware of an unintended behavior when using syngo.plaza. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Missouri, New York, Washington and Wisconsin named
- Medical device recall Battery, 100/115V (Includes charger and connecting cable) The Sarns” Centrifugal System is indicated for use… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns”… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement Report43 statesnamed in where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Battery, 220V (Includes charger and connecting cable) The Sarns” Centrifugal System is indicated for use in… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns”… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement Report43 statesnamed in where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in… Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in… Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in… Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TORQ Sternal Closure Device The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois and New Hampshire named
- Medical device recall 3 PORT “OFF” MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿ ICU Medical, Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall MIRS for MATRIX Spine System Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Indiana, Louisiana, Maryland, Michigan, Montana, New York, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall COULTER PrepPlus The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems… The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16 The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud¿-tip catheters… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 10, 2012ClassClass 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Endoscopic retrieval device When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall BriteField illuminated Suction Device Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Oregon, South Carolina, Utah and Washington named
- Medical device recall Sterile, single-use, disposable electrosurgical electrode holder The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. Class IIIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually… The 8 Fr. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL… HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic… It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head… Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional… Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optilock 2.7 mm Screw Inserter Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate (“lock”) into some of the specified screw heads. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Utah, Virginia and Washington named
- Medical device recall Optilock T15 AO Driver Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate (“lock”) into some of the specified screw heads. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Utah, Virginia and Washington named
- Medical device recall Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate… Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tabs Professional Monitor, includes one wall bracket The monitor may fail to sound an alarm Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tabs Professional Monitor, without wall bracket The monitor may fail to sound an alarm Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tabs Professional Monitor, without pull cord or wall bracket The monitor may fail to sound an alarm Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tabs Professional Voice + Monitor, includes one wall bracket The monitor may fail to sound an alarm Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tabs Professional Voice + Monitor, with wire bracket The monitor may fail to sound an alarm Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to… Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Minnesota, New Jersey, New York, Ohio and Oregon named
- Medical device recall Philips Digital Diagnost with patient carriage Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator Class IIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state 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.