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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall AAMI 3 NONREINF SURGICAL GOWN 3XL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall AAMI 3 FABREINF SURG GOWN LARGE The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Kansas, Louisiana, Massachusetts, Missouri, New Jersey, Ohio, Pennsylvania, Rhode Island, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S)… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690 Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Suture Tray DYNDR1210A SUTURING TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- I86625 DEBRIDEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion IVS3505 ULTRASOUND GUIDED PIV KIT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Port Draw Kit KNV30 PORT DRAW KIT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- LC145 STERILE NICU LINE CHANGE KIT Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 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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