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 Kopf Adapter S Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MS-30 Shaft, Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sunquest Laboratory, version 7.0 not available Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument… Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct,… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the… Cartridges are leaking. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Sysmex XE-2100 Automated Hematology System There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sysmex XE-5000 Automated Hematology System There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sysmex XE-2100C Automated Hematology System There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown… Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical… Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMS AdVance” Male Sling System 720088-01 AMS AdVance” Male Sling System (US) 720088-02 AMS AdVance” Male… American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall R-30H , Diagnostic X-Ray Beam-Limiting Device Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall R-20J , Diagnostic X-Ray Beam-Limiting Device Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage:… Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of… Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general… Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different… Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereColorado, Nevada and Texas
- Medical device recall The brand name of the device is AlgiNot, a dental impression material The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TI Standard Polyaxial Screw Assembly 6.5MM x 55MM The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Tennessee and Wisconsin named
- Medical device recall AC Powered adjustable hospital bed, Prime Bed TL500 The “Retaining washers & Clevis Pins” provided with the AC -powered adjustable hospital beds may fail under certain circumstances. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Illinois, Kentucky, Maryland, Michigan, Ohio, Oregon, Pennsylvania, Texas and Virginia named
- Medical device recall S5 Single Roller Pump 150 Sorin Group USA, Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall S5 Double Roller Pump 85 Sorin Group USA, Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall S5 Mast Roller Pump 85 Sorin Group USA, Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall S5 Mast Roller Pump 150 Sorin Group USA, Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall Sorin C5 Perfusion System Sorin Group USA, Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917 Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip The tip of the product could come loose or unravel. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator It has come to firm’s attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur BR Assay BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aviator Drill Bit Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL… ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after… Oscor, Inc. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Indiana, Kentucky, New Mexico, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall SCP Pump Control Panel Sorin Group USA, Inc. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Michigan and New York named
- Medical device recall SCP Pump Control Panel Sorin Group USA, Inc. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Michigan and New York named
- Medical device recall ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical… The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain… Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Illinois, Louisiana, Missouri, Nevada, New York, Oklahoma, South Carolina, Tennessee, Texas and Utah named
- Medical device recall MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in… Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000… Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with… Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Ventlab Premium Small Child Resuscitator Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee named
- Medical device recall Ventlab Premium Small Adult Resuscitator Possible volume leakage through the inlet valve during compressions of the resuscitator bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide, and Illinois, New York, Ohio and Tennessee 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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