Browse Device Recalls
152 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 152 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 152 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 11, 2019 | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMEN... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C A... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 1... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYND... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- I86625 DEBRIDEMENT TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEME... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICA... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Suture Tray DYNDR1210A SUTURING TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- PT225 PAIN MANAGEMENT TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN) | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRAC... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP41... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TU... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DE... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS1... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion Circumsion Trays as follows: Kit Code Product ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion IVS3505 ULTRASOUND GUIDED PIV KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M10... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D C... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRA... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790 | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DY... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 ... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- LC145 STERILE NICU LINE CHANGE KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Port Draw Kit KNV30 PORT DRAW KIT | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- OR2020 BASIN SET | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC17... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion Chest Tube Trays: Kit Code Product C... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
| Dec 11, 2019 | Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10... | Incomplete seals on the sterile package may compromise the sterility | Class II | Centurion Medical Products Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.