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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
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
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
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker Corporation
Nov 6, 2019 Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder... There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Class II Stryker Instruments Div. of Stryker 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 31, 2019 C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker Corporation
Jul 31, 2019 C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... Class II Stryker Instruments Div. of Stryker 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 25, 2019 Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioP... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.

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.