Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE… NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Hulka Clip is a sterile Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall RECLAIM Distal Reamer Extension Non Sterile Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report27 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus… RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus… RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS… RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall McKesson Cardiology” Hemo intended for complete physiological/hemodynamic monitoring, clinical data… Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New Jersey, Nevada, Oklahoma, Pennsylvania, South Carolina, Utah and Washington named
- Medical device recall StarMedTec LightTrail¿ Reusable Fibers, 365 um Product is not cleared for use with lasers other than the Auriga XL system Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNew York and Texas
- Medical device recall StarMedTec LightTrail¿ Reusable Fibers, 600 um Product is not cleared for use with lasers other than the Auriga XL system Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNew York and Texas
- Medical device recall StarMedTec LightTrail¿ Reusable Fibers, 800 um Product is not cleared for use with lasers other than the Auriga XL system Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNew York and Texas
- Medical device recall ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Product sterility is not assured Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single Product sterility is not assured Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft Product sterility is not assured Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft Product sterility is not assured Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Black Mamba Suture Passer An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, North Carolina, Nevada, New York, South Dakota, Texas and Virginia named
- Medical device recall Green Mamba Suture Passer An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, North Carolina, Nevada, New York, South Dakota, Texas and Virginia named
- Medical device recall Mamba Disposable Nitinol Needle An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, North Carolina, Nevada, New York, South Dakota, Texas and Virginia named
- Medical device recall Biosense Webster’s Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereCalifornia and Washington
- Medical device recall GE Healthcare Carescape Patient Data Module GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data… Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Charnley PN Retract & Handle The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. Class IIFDA’s classOct 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, Illinois, Massachusetts, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MaxLock Extreme Mod-Foot Concave Reamer Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer Class IIFDA’s classOct 15, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 15, 2014ClassClass IIStatusTerminatedWhereMichigan, Missouri, North Carolina, New Mexico, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Philips Expression MR200 MRI Patient Monitoring System During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device’s pole assembly. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical… Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, South Carolina and Utah named
- Medical device recall Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic… Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, South Carolina and Utah named
- Medical device recall Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system,… Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, South Carolina and Utah named
- Medical device recall Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for… Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, South Carolina and Utah named
- Medical device recall ENVOY 500 AST Reagent Kit, reference Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is… Class IIIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach Two (2) failures of the spring link components within the articulated arm assembly. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Precision 500D, Classical R&F System GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems… Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Massachusetts, Mississippi, Ohio, Pennsylvania, Texas and Wyoming
- Medical device recall The Symbia T Series consists of the T16, T6, T2, and T Siemens Medical Solutions USA, Inc. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming
- Medical device recall The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2 Siemens Medical Solutions USA, Inc. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming
- Medical device recall Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use The pediatric breathing circuits can crack prior to and during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 8, 2014ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Louisiana, New Jersey, New York, Ohio, Oregon, Puerto Rico, South Dakota, Texas and Washington named
- Medical device recall ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use… The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional… The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CelluTome Epidermal Harvesting System Blade can shift during shipping which makes the product ineffective. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Trial Lead Kit The Directions for Use (DFU) manual contains information for devices that are not approved in the US. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereIllinois and Texas
- Medical device recall Percutaneous Trial Lead Kit The Directions for Use (DFU) manual contains information for devices that are not approved in the US. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereIllinois and Texas
- Medical device recall Siemens Dimension Vista¿ CHEM 1 CAL Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming 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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