Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034 ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement,… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery. Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting… Class IIFDA’s classNov 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to… Integra received an Urgent Drug Recall Notice from Hospira Inc. Class IIFDA’s classNov 4, 2015in FDA’s Enforcement ReportMarylandthe one state its words name PublishedNov 4, 2015ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall XiO Radiation Treatment Planning System Incorrect Treatment Delivery Using Third Party Fixed Wedges. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall AltiVate Humeral Socket Shell Trial Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Idaho and Pennsylvania
- Medical device recall ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID… Potential for a leak at the tubing to luer bond. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ambitex NMD400 Nitrile Exam Gloves size medium Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm,… This product was produced using a finishing process not identified as part of the manufacturing specification. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software In spine clinical workflows, cross reference lines may be used to determine the position of slices. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement Report22 statesnamed in where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and Washington
- Medical device recall Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Carolina, New York and Oklahoma named
- Medical device recall Thinflap System Case The cases hold surgical instrumentation in place during handling and storage. The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Carolina, New York and Oklahoma named
- Medical device recall ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR -… May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL… May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ConFormis iDUO G2, Right Lateral May contain small amounts of ethylene glycol residue Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output… Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perifix Continous Epidural Anesthesia Pain Control Trays Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PORT-A-CATH Plastic Hub Needles, 0.9mm The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and… Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam… The wrong sterilization time was on the label. Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana, Louisiana, Ohio, Pennsylvania, Texas and West Virginia named
- Medical device recall TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical… During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control… Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Sterility of device is compromised due to breach in the packaging Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Sterility of device is compromised due to breach in the packaging Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Sterility of device is compromised due to breach in the packaging Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Sterility of device is compromised due to breach in the packaging Class IIFDA’s classOct 28, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Toshiba Aquilion CT System TSX-101A If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Aquilion CT System TSX-301A If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Aquilion CT System TSX-301B If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Aquilion CT System TSX-301C If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Aquilion CT System TSX-302A If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Aquilion CT System TSX-303A If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision… ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the… Class IIFDA’s classOct 21, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Missouri and Wisconsin
- Medical device recall Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / One Distal Access Catheter intended for distribution in Korea, was found at a US location. Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportKentuckythe one state its words name PublishedOct 21, 2015ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall NicoletOne Software v5.94 When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active… Class IIFDA’s classOct 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2015ClassClass 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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