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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.

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DateProductReasonClassFirm
Dec 11, 2019 Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- ENT SNUF3 SNUFFER KIT Y Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT U... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Oct 24, 2019 Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT... Sterile packaging incomplete seals may compromise sterility of the product Class II Centurion Medical Products Corporation
Aug 28, 2019 Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to ... A mismatch between the angle of the hole in the base and the angle of the bell, which may cause ... Class II Centurion Medical Products Corporation
Aug 28, 2019 Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to c... A mismatch between the angle of the hole in the base and the angle of the bell, which may cause ... Class II Centurion Medical Products Corporation
Jul 15, 2019 Port full Access Tray Product Code: DT19330 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 Kit, Port Access Product Code: DYNDC1582A Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 Maintenance Flush Kit/Blood Draw Product Code: DT19335 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 1, 2019 STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used ... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for perform... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driv... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used f... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for lac... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceratio... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:Th... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performi... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Drivelin... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jul 1, 2019 DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit i... Potential for sterile packaging to be compromised Class II Centurion Medical Products Corporation
Jun 24, 2019 YNHH SCOPE KIT Kit Code: MNS10475 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 24, 2019 EPISTAXIS TRAY Kit Code: MNS10165 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 24, 2019 NOSEBLEED TRAY Kit Code: MNS3885 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manuf... Class II Centurion Medical Products Corporation
Jun 7, 2019 Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes du... Class I Centurion Medical Products Corporation
Jun 1, 2019 Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Hepari... False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutaine... Class II Centurion Medical Products Corporation
Apr 24, 2019 CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 PEDIATRIC PICC INSERTION TRAY CVI4450 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CAP BUNDLE KIT DYNDC2137 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 IV KIT - SORBAVIEW IVS3475 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CENTRAL LINE BUNDLE ECVC6375 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 PORT AND IO ACCESS DRESSING KIT DT15780A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 IV START KIT IV8440 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 UVC TRAY UVT875 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 INFUSA PORT KIT DYNDC1840F Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 TRIPLE LUMEN BUNDLE KIT ECVC1540 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 STERILE CAP CHANGE KIT DYNDC1946B Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CAP CHANGE KIT DYNDC1496B Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 IV SECUREMENT KIT IVS3405 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 INFUSA PORT KIT DYNDC1840E Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CVC BUNDLE, 20CM, 3L, PI ECVC5120A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 INVASIVE PROCEDURE TRAY MNS9510 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CVC BUNDLE, 20CM, 4L, PI ECVC5095 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... 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.