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 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA… The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Louisiana, Maryland, Minnesota, Missouri, Montana, Nebraska, New Mexico, Ohio, Pennsylvania, South Carolina, Utah and Wyoming named
- Medical device recall ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard;… Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereFlorida, Texas and Virginia
- Medical device recall ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard;… Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereFlorida, Texas and Virginia
- Medical device recall GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by:… Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report21 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Virginia and Washington
- Medical device recall Smith Medical, Deltec Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Smiths Medical, Deltec Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position. Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report51 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report50 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe… BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report21 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall TEGRIS system Four labels of the Tegris System include: Emergency button MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNew York and Pennsylvania
- Medical device recall Monaco RTP System Radiation treatment planning Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Florida, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Washington named
- Medical device recall Monaco RTP System Radiation Therapy Treatment Planning System Patient needs to be positioned as indicated by the treatment plan. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report28 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for… Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall SmartSite Low Sorbing Infusion Set CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereArizona, California, Florida and Tennessee
- Medical device recall ABX PENTRA Calcium CP Reagent HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP… Class IIIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall CareFusion Gravity Set CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Synthes Oracle Spacer System Slap Hammer This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereColorado, Pennsylvania, Tennessee, Virginia and Washington
- Medical device recall The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote… The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereMichigan, Virginia and Wisconsin
- Medical device recall Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois and Nebraska named
- Medical device recall SmartSite Low Sorbing Infusion Set CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, North Carolina, Oklahoma, Pennsylvania, Texas and Wisconsin named
- Medical device recall Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such. A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Kansas and Pennsylvania
- Medical device recall Juno DRF System It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12”x12”) and 15x15 (6”x6). Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, New York, Ohio, Pennsylvania and Utah
- Medical device recall Outlook ES pump is intended for use with B This notice is being provided in follow up to the field correction initiated by B. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Illinois, Louisiana, Maryland, Maine, Minnesota, North Carolina, New Jersey, New York, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks… The products may have been stored at temperatures outside their required storage conditions. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah and Washington named
- Medical device recall Hemoccult II BRAND SENSA elite The products may have been stored at temperatures outside their required storage conditions. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah and Washington named
- Medical device recall ProTime Microcoagulation System The products may have been stored at temperatures outside their required storage conditions. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah and Washington named
- Medical device recall AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report21 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Ohio, Oregon, Pennsylvania, Puerto Rico and Texas
- Medical device recall T8 REMOVAL HEAD One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Georgia and Washington named
- Medical device recall GE Healthcare, CARESCAPE Monitor B850 GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial… During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment… Product not cleared for sale/use in the United States. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereColorado, Illinois, Maryland and New Hampshire
- Medical device recall C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment… Product not cleared for sale/use in the United States. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereColorado, Illinois, Maryland and New Hampshire
- Medical device recall C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment… Product not cleared for sale/use in the United States. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereColorado, Illinois, Maryland and New Hampshire
- Medical device recall C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Product not cleared for sale/use in the United States. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereColorado, Illinois, Maryland and New Hampshire
- Medical device recall Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement… One of the dental implants do not have the internal hex feature. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, District of Columbia, Delaware, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee and Texas named
- Medical device recall Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the… One of the dental implants do not have the internal hex feature. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, District of Columbia, Delaware, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee and Texas named
- Medical device recall Blanketrol III During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Brilliance CT 6, M/N 728256 The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Wisconsin and West Virginia named
- Medical device recall Device Name: Terino Square Chin-Style II-Medium Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Kentucky and New York named
- Medical device recall Zeppessis’ reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste… Zeppessis’ reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Oregon and Washington
- Medical device recall Responder 5 is a nurse call communication system that connects patients with staff in a hospital A counterfeited electronic component was identified in the products affected. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054 Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Maryland, Mississippi, North Carolina, Ohio, Pennsylvania, South Carolina and Texas named
- Medical device recall BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BIORAPTOR 2.9 mm Suture Anchor with DURABRAID” Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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