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 TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 1 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 2 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 3 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 4 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 5 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 6 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 7 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 8 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 9 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall LUSTER HIP SZ 10 Packaging: The product was DePuy Orthopaedics, Inc. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall AirLife¿ MiniSpacer¿ MDI Dispenser Adapter Internal data identified a molding defect in the 15 mm O.D. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereCalifornia and Kentucky
- Medical device recall PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall S4 Cervical (S4C) Revision Instruments (FW099R and FW101R) Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital… Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Louisiana, Nevada, Ohio and Texas named
- Medical device recall Vacuette Quickshield Complete Plus, 21G x 1 : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose… Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Mississippi, Ohio, Pennsylvania, Tennessee and Virginia named
- Medical device recall Microbiologics 217 Osseo Avenue North, St Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia and Vermont named
- Medical device recall Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. The main harness connector was manufactured without the required back shield sealing protection. Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains… Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall Fresenius NaturaLyte Liquid Acid Concentrate Risk of Alkalosis with acetate containing dialysis acid concentrates FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo (powder) Acid Concentrate Risk of Alkalosis with acetate containing dialysis acid concentrates FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product… Lidstock of product does not contain chlorhexidine contraindication and contains wording “contains no medication” on the label. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2012ClassClass IStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Hartmann Econolux Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Kentucky, Missouri, Mississippi, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Hartmann Sterilux Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Kentucky, Missouri, Mississippi, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical… An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as… An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Rose Bed An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker MA204 Bed An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as… An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta 2 Bed During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OEC Uroview 2800 Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display,… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Formula Shaver Handpiece (with buttons) Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Michigan, North Carolina, Nevada, Oklahoma, Texas and Wisconsin named
- Medical device recall BCS(R) Behring Coagulation System, Device Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane… Product was packaged with the incorrect port and does not match the label. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Washington named
- Medical device recall Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with… Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
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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