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 LATITUDE¿ Patient Management System Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel… Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Ref: VP1600 HD Still Capture System ConMed Linvatec The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for… Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands and Wisconsin named
- Medical device recall Rostorelle L, Polypropylene Mesh Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Missouri, New Hampshire, Ohio, Rhode Island and Virginia named
- Medical device recall Molift Smart 150 The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Vermont and Washington named
- Medical device recall Molift Smart 150 The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Vermont and Washington named
- Medical device recall Cardinal Health hCG Cassette Rapid Test Alere San Diego Inc. Class IIIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 29, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TD-Synergy. Laboratory Information System. Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has… Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Kentucky, Louisiana, Nevada, Pennsylvania and Rhode Island named
- Medical device recall cobas¿ 4800 system z480 instrument In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereMissouri, Pennsylvania and Tennessee
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J-… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade… Product coatings require 510K approval. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall MEDITECH Bi-Directional interactive Communication Analyzer Interface Incorrect transmission of laboratory results. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 29, 2013ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner DePuy Orthopaedics, Inc. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE Separation Technology, Inc. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Kansas, North Carolina and Pennsylvania named
- Medical device recall Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module… When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Triathlon Femoral Distal Augment- Left Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph… Class IIFDA’s classMay 29, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 29, 2013ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Indiana, Mississippi, North Carolina, New Jersey, Oklahoma, Texas and Wisconsin named
- Medical device recall Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AMS 800¿ Urinary Control System American Medical Systems, Inc. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall AMS 800¿ Urinary Control System American Medical Systems, Inc. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light… Insight Instruments, Inc., Stuart, FL is recalling M.I.S. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereIllinois and Indiana
- Medical device recall Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 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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