Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Arterial Line Kit 20ga X 3” Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, North Dakota, South Carolina, Texas and Virginia named
- Medical device recall PAC Tray/5 Catheter Introducer Tray 8F Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, North Dakota, South Carolina, Texas and Virginia named
- Medical device recall SWIN 2017 database Potential for out of range microbial results Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611… The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereIowa, North Carolina, Ohio and Virginia
- Medical device recall VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW Nonconforming product; length of the product measured shorter than the labeled length. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and Michigan named
- Medical device recall Insufflation tubing to be used with varies insufflator units The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. Class IIIFDA’s classMay 20, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedMay 20, 2020ClassClass IIIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall EVA Floor Lifts After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall iChem¿VELOCITY Urine Chemistry System A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iQ200 Series Urine Microscopy Analyzer- All A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Iincorrectly packaged without the required lidocaine as labeled Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report14 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereArizona, Connecticut, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, North Dakota, Nebraska, New York, Ohio, South Dakota and Texas
- Medical device recall Quickie/Zippie powered wheelchair Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportMontanathe one state its words name PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereMontana
- Medical device recall TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage:… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage:… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage:… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides… Failure to prime due to an assembly error Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Sheath Introducer Kit labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medical device recall Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile… Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile… Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin… Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci Xi Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Illinois, Kentucky, Massachusetts, Maryland, Michigan, New Jersey, New York, Ohio, Texas and Virginia
- Medical device recall da Vinci X Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Illinois, Kentucky, Massachusetts, Maryland, Michigan, New Jersey, New York, Ohio, Texas and Virginia
- Medical device recall Gore DrySeal Flex Introducer Sheath The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DeRoyal Sterile Custom Kits DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Maryland, Minnesota, North Dakota, New York, Rhode Island and Tennessee
- Medical device recall BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F… The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 20, 2020ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Massachusetts, Maryland, New Jersey, New York and Texas named
- Medical device recall Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major… It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Illinois, Minnesota, Montana, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive… It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Illinois, Minnesota, Montana, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV The products have the potential to leak between the connection of the male luer and the yellow striped tubing. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV The products have the potential to leak between the connection of the male luer and the yellow striped tubing. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV The products have the potential to leak between the connection of the male luer and the yellow striped tubing. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or… There is potential for a white paper-type residue attached to the catheter. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall Analyte specific reagent False positive reaction on the reagent. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND” ED Quick Kit 3FR 6cm Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND”XL Alternate Site Kit, 4Fr Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit Saline Flush Syringe compromised sterility due to holes in the packaging. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named
- Medical device recall Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass 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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