Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Feb 8, 2018 Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Cathet... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel... The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reportin... Class II Life Technologies Corporation
Feb 8, 2018 POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F ... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane ... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... Class II Stanbio Laboratory, LP
Feb 8, 2018 IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane ... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Cathe... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Produc... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Cathe... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Cathet... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray syst... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray syste... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyureth... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Cath... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BV... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM... Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly th... Class II Tornier, Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Cathe... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane ... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Cathet... The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum cont... Class II Bard Peripheral Vascular Inc
Feb 8, 2018 Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 7, 2018 Human Fetal Hemoglobin (HBF-1) FITC Conjugate Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual br... Class II Life Technologies Corporation
Feb 7, 2018 GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter Syste... RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will resu... Class II Advanced Instruments, LLC
Feb 7, 2018 HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us... Update XL¿ device software to version A.03. This includes enhancements to the Operational Check... Class III Philips Electronics North America Corporation
Feb 7, 2018 Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. End... Device may display a battery missing error. Class II Medela Inc
Feb 7, 2018 Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to ... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ... Class II Halyard Health, Inc
Feb 7, 2018 Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿Sy... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ... Class II Halyard Health, Inc
Feb 7, 2018 VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AI... The manufacturer received complaints indicating that the device's central handle holder detaches ... Class II GETINGE US SALES LLC
Feb 7, 2018 Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿Syst... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ... Class II Halyard Health, Inc
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 8005082... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Feb 6, 2018 Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product... Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with ... Class II Baxter Healthcare Corporation
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Feb 5, 2018 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualita... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 5, 2018 ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative scr... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 5, 2018 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 ZYMUTEST HIA MonoStria qualitative screening assay intended for the global de... Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... Class II Hyphen BioMed
Feb 5, 2018 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, 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.