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Browse Device Recalls

950 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 950 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 950 FDA device recalls in MI.

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DateProductReasonClassFirm
Jun 25, 2019 K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Access... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
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
Apr 24, 2019 CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070 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 WITHOUT CATH CVI4600 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355 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 MULTIMED, 3L, 20CM ECVC6060 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 DT20310 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 ECVC5120 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 Neonatal Cap Change Kit DT20315 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535 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.