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 5, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE… Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care… Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test… Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereColorado, District of Columbia, Iowa, Maryland, North Carolina, New Jersey, Ohio, Virginia and Wisconsin
- Medical device recall Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE Lots were labeled with incorrect expiration dates on secondary package (carton). Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE Lots were labeled with incorrect expiration dates on secondary package (carton). Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PedFuse Reset Screw During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereTexas and Virginia
- Medical device recall SEAC Advanced Dental System ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set… A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Georgia, Idaho, Kansas, Louisiana, Massachusetts, Missouri, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Texas and Wisconsin named
- Medical device recall FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kansas, Kentucky, Massachusetts, North Carolina, Nevada, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack… Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kansas, Kentucky, Massachusetts, North Carolina, Nevada, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4… Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kansas, Kentucky, Massachusetts, North Carolina, Nevada, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of… Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kansas, Kentucky, Massachusetts, North Carolina, Nevada, New York, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iba COMPASS SW Version 3.0 The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Massachusetts, New York, Ohio, Oklahoma and South Carolina
- Medical device recall Product is labeled in part: LIST NO. 43449 Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Pennsylvania, South Dakota, Texas, Utah, Virginia and Washington named
- Medical device recall Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969 Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile This is an expansion of the June 2013 recall of NexGen Micro components. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile This is an expansion of the June 2013 recall of NexGen Micro components. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used… This is an expansion of the June 2013 recall of NexGen Micro components. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used… This is an expansion of the June 2013 recall of NexGen Micro components. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices… This is an expansion of the June 2013 recall of NexGen Micro components. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which… Package labeling indicates both “latex free” and “contains natural rubber latex” . Class IIFDA’s classDec 18, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereGeorgia, Louisiana and New York
- Medical device recall Axillent Debakey Grasping Forceps KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and New York, Pennsylvania and Texas named
- Medical device recall Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne,… Maquet has received an increase in the number of complaints for “self-activated/remains activated/overheats” for the Hemopro VH-30000, “Hemopro 1” Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica… Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Illinois and Washington named
- Medical device recall Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous… There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Digital Pathology System (DPS) Software version 1.1 The Omnyx” Integrated Digital Pathology system, which… There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Coulter LH 750 Hematology Analyzer Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coulter LH 780 Hematology Analyzer Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge… A labeling correction was initiated related to the Surgical Technique Guide J5606-C “TomoFix Osteotomy System” due to the potential for a surgical delay if the… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN… Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana, Louisiana, Michigan, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to… As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to… As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to… As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in… Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the… Two complaints were received in which it was reported that the stem would not lock into the tibia. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Opal Orthodontics by Ultradent Ultradent Products Inc. Class IIIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 18, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California, Ohio, Tennessee, Utah, Virginia and Washington named
- Medical device recall VerifyNow IIb/IIIa Test, 10-Test Kit Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Connecticut, District of Columbia, Indiana, New Jersey, New Mexico, New York, Pennsylvania and Texas named
- Medical device recall Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient’s… Possible fatigue failure of the plastic joint may occur after an average use of seven years. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas and Washington
- Medical device recall HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253… GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Missouri, North Carolina, New Jersey, Pennsylvania, Texas and Wisconsin named
- Medical device recall Synthes Soft Tissue Retractor Small Extendible The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software… There is the potential for the vial volume of “in use” Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Easy Diagnost Eleva Universal Fluoroscopic applications The delivered application software was an outdated version to the model of equipment. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Massachusetts, Minnesota, New Hampshire, Ohio, Oregon, South Carolina, Texas and Washington named
- Medical device recall TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC:… Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab… Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERITITE Containers: STERITITE Container Kit, 1/4 size, 3” high Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of… Class IIIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIIStatusTerminatedWhereNationwide
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.