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 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE… GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall FreeStyle Blood Glucose Test Strips Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall FreeStyle Lite Blood Glucose Test Strips Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA… Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall 1) Nephros SafeShower FH - 15 filters per box Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A… Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereFlorida and Maryland
- Medical device recall Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 150CM 2 TIP Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand GDC-18 360 18MM X 30CM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand GDC VORTX 2MM X 3MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 4MM X 10MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 4MM X 15MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 4MM X 20MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 4MM X 30MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 5MM X 15MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand COMPLIANT 5MM X 30MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand SUPER COMPLIANT 4MM X 7MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker brand SUPER COMPLIANT 7MM X 15MM Products were shipped labeled with “use by” dates that exceed currently available shelf-life data. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereCalifornia, Montana, North Dakota, Oklahoma, Utah, Washington and Wisconsin
- Medical device recall HemosIL Normal Control 1 UNASSAYED HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HemosIL Low Abnormal Control 2 UNASSAYED HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HemosIL High Abnormal Control 3 UNASSAYED HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended… Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198)… Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD)… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access Immunoassay Systems Reaction Vessels Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000 Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000 Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KayserBetten Some joints on the doors of a limited number of IDA beds may loosen or separate over time which can cause the doors to drop outward and cause injury. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Minnesota, Missouri, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx… Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Indiana, Michigan and Tennessee named
- Medical device recall InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems,… Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1,… KARL STORZ Endoscopy America, Inc. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. “ Examination and treatment… KARL STORZ Endoscopy America, Inc. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5… Boxes labeled as CIP5 may contain cartridges of AMP5. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall remel RapID Yeast Plus System, 20 tests The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Idaho, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M ESPE Imprint II Regular Body Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic… This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Georgia, North Carolina, New Jersey, New York, Ohio, Texas, Virginia and Washington
- Medical device recall Streptex* kit The product may give weak or false negative test results. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Streptex* Latex D The product may give weak or false negative test results. Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 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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