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 BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX” Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID” Suture, White / Black Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RAPTORMITE” 3.7 mm PLLA with two ULTRABRAID” Sutures Size 0 and Needles Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX” Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID”) with Needles Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Advantage Workstation, READY View Application GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereIllinois, Minnesota, New Jersey, New York and Virginia
- Medical device recall 3M Scotchcast, Wet or Dry Cast Padding 3M is conducting a voluntary product recall of selected lots of 3M” Scotchcast” Wet or Dry Cast Padding. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report33 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Synthes Cannulated Distal Femoral Nail (Trauma Nail) Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall ACL TOP (Base) Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in… Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in… Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP 700 LAS Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP 700 CTS Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP 300 and ACL TOP 300 CTS (Japan) Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ACL TOP 500 CTS Potential carryover issue that can can cause shortened APTT clotting times on the instrument. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Vygon 14 Microbore Extension Set with Bionector, CMS-814-1 Microbore tubing disconnecting from male luers on the extension sets. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Minnesota, New Jersey, New York, Pennsylvania and Virginia named
- Medical device recall Central Dressing Change Kit Microbore tubing disconnecting from male luers on the extension sets. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Minnesota, New Jersey, New York, Pennsylvania and Virginia named
- Medical device recall GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania and Tennessee named
- Medical device recall POWERWAND Safety Introducer with Extended Dwell Catheter Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereMichigan and Texas
- Medical device recall King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for… Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. Class IIIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedSep 25, 2013ClassClass IIIStatusTerminatedWhereNew York
- Medical device recall GE Healthcare, CARESCAPE Monitor B650 GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7,… GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Texas and Wisconsin named
- Medical device recall VisuALIF,System consisting of a ‘U’ shaped PEEK block in two footprint configurations, four heights and three… The product has the potential to be laser marked as a Medium when it actually is a Small. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall NX3 Try-In Gel Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for… Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Kansas, North Carolina, Nevada, New York, Oklahoma, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin named
- Medical device recall Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 18, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, South Carolina, South Dakota, Texas and Wisconsin 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.”
Your shortlist0 of 4
Add one more to compare.