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 Zeiss brand OPMI Pentero C, Surgical microscope and accessories Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1 Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from… Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 8 mm Monopolar Curved Scissors (a.k.a Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Canister: CO2 canister with GE GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View,… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Idaho, Michigan, New Jersey, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Indiana, Kentucky, New York, Ohio, Oregon, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Indiana, Kentucky, New York, Ohio, Oregon, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall LPC Fine Mesh Cassette for the Leica LPC Printer An LPC Fine Mesh Cassette failed to stay closed during processing operations. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona and Kentucky named
- Medical device recall Comfort brand Ear-Loop Face Mask Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of “Differential Pressure of only 1.6 Delta P (mm H2O/cm2)” as… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Part 510031 Disposable Single Infusion Pump, quantity Includes.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510180 Disposable Single Infusion Pump, .. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),.. Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Active Articulation E1 Biomet is recalling Active Articulation E1 Hip Bearing implants. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Hill-Rom 1000 Bed, Product No Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Trocar With Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Fixation Cannula - 5mm Short Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Versaport Bladeless Optical Fixation Cannula - 5mm Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SlingBar 350 Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Utah, Washington and Wisconsin named
- Medical device recall SlingBar 360 Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Utah, Washington and Wisconsin named
- Medical device recall SlingBar Wide 670 Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Utah, Washington and Wisconsin named
- Medical device recall SlingBar Standard Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Utah, Washington and Wisconsin named
- Medical device recall Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for… Affected products have a labeled expiration date of one year too long. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Indiana and South Carolina named
- Medical device recall Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for… Affected products have a labeled expiration date of one year too long. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Indiana and South Carolina named
- Medical device recall Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for… Affected products have a labeled expiration date of one year too long. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Indiana and South Carolina named
- Medical device recall E-Z WIDER BARIATRIC CHAIR BED An EZ Wider bed (capacity of 1000 lb. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Indiana named
- Medical device recall BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143… Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report44 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Straight Impactor - Dorado IBC During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Massachusetts and Texas named
- Medical device recall The Zimmer Air Dermatome This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Zimmer Air Dermatome II This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Zimmer Air Dermatome II This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Digitex Absorbable Polydiaxanone Suture, Size 2-0 Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereKentucky, Michigan, Ohio, Puerto Rico, Texas and Virginia
- Medical device recall AGFA Digital Radiography X-Ray System DX-D 100 Agfa’s DX-D 100 is indicated for use in providing diagnostic… Customers could potentially experience intermittent, unintended and illogical movement when using the product. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, Tennessee, Virginia, West Virginia and Wyoming named
- Medical device recall Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON… The firm received complaints for unintended movements. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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