Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Remisol Advance Software (Driver Architect) Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UniCel DxH800 The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Hawaii, Maryland, Ohio and Washington
- Medical device recall UniCel DxH600 The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Hawaii, Maryland, Ohio and Washington
- Medical device recall UniCel DxH Slidemaker Stainer The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Hawaii, Maryland, Ohio and Washington
- Medical device recall Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended… Potential incorrect marking and color identification of Piranha screw. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Georgia, Louisiana, Maryland, Nevada, New York, Ohio and Texas
- Medical device recall Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN… Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950 Navilyst Medical, Inc. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures… Manufactured with the incorrect anchor outer body Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Kansas, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall enGen Track System with TCAutomation Software Version 4.2 A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Missouri, North Carolina and New York
- Medical device recall pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined… Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) Listeria monocytogenes contamination of non-sterile plated media Class IIFDA’s classDec 13, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont and Washington
- Medical device recall Accu-Chek Connect diabetes management software app Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD PhoenixTM AP Potential unexpected movement of robot arm Class IIIFDA’s classDec 13, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 13, 2017ClassClass IIIStatusTerminatedWhereCalifornia, North Carolina and Tennessee
- Medical device recall DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage… Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Indiana and Pennsylvania named
- Medical device recall Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3 Possible inner labeling and packaged device not matching the outer label on the box. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3 Possible inner labeling and packaged device not matching the outer label on the box. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or… Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNew York and Wisconsin
- Medical device recall Fukuda Denshi patient monitor For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has… Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Morning Life Distribution of unapproved devices with incorrect air compression level setup Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Texas named
- Medical device recall Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage:… Distribution of unapproved devices with incorrect air compression level setup Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Texas named
- Medical device recall Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a… A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Precision Glide Needle 18G x 1 RB Hub damage resulting in breakage and/or leakage during use. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereIllinois, Kentucky, New York, Ohio and Virginia
- Medical device recall CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. Product may have incorrect cation information detailed on the product label. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereAlabama, Maryland, Maine, North Carolina and Tennessee
- Medical device recall SMARTABLATE RF System Generator Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement Report15 statesnamed in where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Illinois, Indiana, Michigan, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PENTARAY NAV High-Density Mapping Catheter. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. Class IIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arctic Sun ArcticGel Pads - Medium Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled… Class IIIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 13, 2017ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall BD Phoenix PMIC-107 BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereConnecticut, Florida, North Carolina, New Mexico, Pennsylvania, Texas, Virginia and Wisconsin
- Medical device recall BRAINLAB EXACTRAC VERO Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516… Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919 Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920 Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921 Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the… A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the… Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ROSA Surgical Device 2.5.8 Issue with optional neuro-endoscopy module detected under specific conditions during internal testing. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereArkansas, Michigan, Ohio and Texas
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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