Browse Device Recalls
136 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 136 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 136 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular Inc |
| Feb 8, 2018 | POWERPORT ClearVUE Slim with Smooth Septum, 6F 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 |
| Sep 22, 2017 | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g... | During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core ... | Class II | Bard Peripheral Vascular Inc |
| Mar 28, 2017 | MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 P... | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire inste... | Class II | Bard Peripheral Vascular Inc |
| Jul 6, 2016 | Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number... | May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. | Class II | Bard Peripheral Vascular Inc |
| Feb 9, 2016 | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J... | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... | Class II | Bard Peripheral Vascular Inc |
| Feb 9, 2016 | Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicate... | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... | Class II | Bard Peripheral Vascular Inc |
| Feb 4, 2016 | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuid... | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles becau... | Class II | Bard Peripheral Vascular Inc |
| Jan 5, 2016 | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. I... | Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product ... | Class II | Bard Peripheral Vascular Inc |
| Jan 5, 2016 | Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. I... | Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm ... | Class II | Bard Peripheral Vascular Inc |
| Oct 19, 2015 | FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Siz... | Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of th... | Class II | Bard Peripheral Vascular Inc |
| Apr 9, 2015 | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm... | The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having s... | Class II | Bard Peripheral Vascular Inc |
| Mar 23, 2015 | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Cod... | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because i... | Class II | Bard Peripheral Vascular Inc |
| Mar 17, 2015 | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm ... | Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kit... | Class II | Bard Peripheral Vascular Inc |
| Mar 13, 2015 | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950... | IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypers... | Class II | Bard Peripheral Vascular Inc |
| Aug 26, 2014 | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) ... | Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at... | Class II | Bard Peripheral Vascular Inc |
| Sep 30, 2013 | Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX0... | Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because... | Class I | Bard Peripheral Vascular Inc |
| May 28, 2013 | BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm... | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of dev... | Class II | Bard Peripheral Vascular Inc |
| Apr 16, 2013 | BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended... | Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / l... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A;... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide;... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular Inc |
| Jan 23, 2013 | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), Ultr... | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... | Class II | Bard Peripheral Vascular 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.