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 6, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Philips BuckyDiagnost Radiographic An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respironics V60 Ventilator Respironics California, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall SybronEndo Elements Obturation Unit A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SybronEndo Replacement AC Power Cord, US Elements Obturation A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by… The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems Biomet Trauma (“Biomet”) has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Michigan, Montana, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Texas and Wisconsin named
- Medical device recall Superior Approach Resection Guide Assembly Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Kentucky, Texas, Utah and Wisconsin named
- Medical device recall Aperio ScanScope System Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System There was an error on the outer labeling of this device. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York and Pennsylvania named
- Medical device recall GE Healthcare, PET VCAR GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Illinois, North Carolina, New York, Ohio, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall BC Hammock Mesh Sling (Medium), product number, 537005 The product does not meet the firm’s size standards, the product was produced in the incorrect size. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Ohio and Texas named
- Medical device recall BC Hammock Mesh Sling (Large), product number, 537030 The product does not meet the firm’s size standards, the product was produced in the incorrect size. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Ohio and Texas named
- Medical device recall BC Hammock Mesh Sling (Small), product number, 537010 The product does not meet the firm’s size standards, the product was produced in the incorrect size. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Ohio and Texas named
- Medical device recall BC Hammock Mesh Sling (Junior), product number, 537005 The product does not meet the firm’s size standards, the product was produced in the incorrect size. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Ohio and Texas named
- Medical device recall VITROS Chemistry Products-HCY Reagent The firm is recalling the specific lot due to lower than expected results. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Maine, New Jersey, Oklahoma, Tennessee, Texas, Washington and West Virginia named
- Medical device recall Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage:… Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 26, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Echelon, Echelon Oval and Oasis MR imaging device systems Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Kansas, Kentucky, Maryland, North Carolina, North Dakota, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run… WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, North Carolina, Ohio, Texas and Wisconsin named
- Medical device recall MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide… A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE… The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brand Name: AFX” Introducer System Endologix, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 19, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, Indiana, Michigan, New Hampshire, New Jersey and New York named
- Medical device recall TX1 Tissue Removal System disposable handpieces American Optisurgical, Inc. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in… The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StarDental Classique(TM) Diamond Dental Bur Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Indiana, New Jersey, Nevada, New York, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall AMICUS Exchange Kit Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in… The product has the potential for false negative or delayed reaction for Arginine (ARG) results. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast… Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker’s and support catheters… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast… Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker’s and support catheters… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall MICROSHEATH¿ - 0.066 Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker’s and support catheters… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker’s and support catheters… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VIA Medical Collection Bag International Biomedical has received reports of interference between the collection bag and the extension set connectors. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder) Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking… Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking… Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking… Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas,… Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood… Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA… Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QuickDraw Venous Cannula with Insertion Kit Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing… Utah Medical Products, Inc. Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kentucky, Missouri, Nebraska, New York and Ohio named
- Medical device recall Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general… The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement Report29 statesnamed in where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia and Washington
- Medical device recall GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE lack of sterility assurance Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass 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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