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 6, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high… STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation… T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction… T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers. A shipment mix-up took place. Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Florida and Ohio named
- Medical device recall Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator… SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with “0” standard. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Indiana and Washington named
- Medical device recall Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Software issue: a violation of 21 CFR 1020.31(a). Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optima XR200amx Software issue: a violation of 21 CFR 1020.31(a). Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard Foley procedural trays Incomplete seal on sterile packages of product. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CMS-8412-R2 Custom Cysto Pack containing 2 oz The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Michigan, New York and Pennsylvania named
- Medical device recall CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Michigan, New York and Pennsylvania named
- Medical device recall CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used… The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Michigan, New York and Pennsylvania named
- Medical device recall CMS-2981-R3 Arthrogram Tray containing 2 oz The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Michigan, New York and Pennsylvania named
- Medical device recall Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T) There is a possibility that the screw channel that holds the rod in place may be out of tolerance. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Minnesota, Nevada, Oklahoma and Texas named
- Medical device recall SUN|DASH RADIUS 252 tanning system The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The SYSTEM 1E Liquid Sterilant Processing System The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BLOM-SINGER indwelling TEP Occluder Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. Class IIIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall STERRAD 100S Cassette, Batch # 12A077 Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on… Class IIIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall STERRAD NX Cassette, Batch # 12A078 Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on… Class IIIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10 There is potential for the sterility of the product to be compromised. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of… Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Maryland named
- Medical device recall Siemens Uroskop Access Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Michigan, Mississippi, Tennessee and Texas named
- Medical device recall Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200… In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part… The display on the system has the potential to change. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sterile Empty Vial and Injector Reports of leaking during filling and administration. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, 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 Wyoming
- Medical device recall Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1,… Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safety monitor included with System 8000 Base The Sarns” Modular Perfusion System 8000 is indicated for use… Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm… Exactech Inc. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas named
- Medical device recall Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050,… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Iowa, Kansas, North Carolina and Texas named
- Medical device recall Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system… The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARTO 3 V1.05(FG-5400-00) The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom… Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia and Wisconsin named
- Medical device recall GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. Class IIFDA’s classSep 19, 2012in FDA’s Enforcement Report33 statesnamed in where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron Class IIFDA’s classSep 19, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Newport HT70 and HT70 Plus Ventilators May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IStatusTerminatedWhereNationwide
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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