Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3) Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE ¿ 1000 CEA Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125) Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125) Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE ¿ 1000 TG Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ Cyclosporine The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ DHEA-SO4 The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ Folate (FOL) Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ HBc IgM Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3) Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020 There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Nevada, Ohio, Oregon, South Carolina, Tennessee and Texas
- Medical device recall Straumann¿ Emdogain 0.15 ml 5-Pack A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann¿ Emdogain 015, USA A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann¿ Emdogain 0.3 ml Multipack USA A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann¿ Emdogain 0.3 ml Multipack A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann¿ Emdogain 0.7 ml Multipack USA A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann¿ Emdogain 0.7 ml Multipack A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Syngo.plaza software VB10A Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display,… Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125… Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereCalifornia and Georgia
- Medical device recall ATTUNE Revision CRS Femoral LT SZ 5 Cemented There may be burrs on the extraction hole threads. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereFlorida, Missouri and Pennsylvania
- Medical device recall ATTUNE Revision CRS Femoral RT SZ 5 Cemented There may be burrs on the extraction hole threads. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereFlorida, Missouri and Pennsylvania
- Medical device recall Lactosorb RapidFlap, bone plate The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Missouri, North Carolina, South Carolina, Texas and Wisconsin
- Medical device recall BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Small Patient ECC Pack BEQ-TOP 22301 The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Adult ECC Pack BEQ-TOP 22300 The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 33500 3/8” ECC PACK The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 40700 HUNTINGTON The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 22702 ECC W/HMOD 30000 The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BO-TOP 20705 SMALL PATIENT 1/4 The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 22701 The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 24202 ADULT ECC The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 33700 ECC 3/8” PACK, Custom Tubing Pack with Bioline Coating The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 38900 ECC PACK, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall BEQ-T 25501 3/8” Better Bladder Pack, Custom Tubing Kit The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas and Washington
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.