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.

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Date	Product	Reason	Class	Firm
Dec 12, 2025	Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ing...	Due to damage to outer tray that can potentially compromise the sterile barrier	Class II	Bard Peripheral Vascular Inc
Nov 6, 2025	Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,	Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration pr...	Class II	Bard Peripheral Vascular Inc
Aug 21, 2025	Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden...	Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification featu...	Class II	Bard Peripheral Vascular Inc
Feb 5, 2025	Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x...	Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce th...	Class I	Bard Peripheral Vascular Inc
Sep 30, 2024	Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 1...	Disposable biopsy instruments were potentially manufactured missing the backend notch retention f...	Class II	Bard Peripheral Vascular Inc
Sep 4, 2024	The EVSRF catheter is a sterile, single-use disposable medical device for end...	The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The r...	Class II	Bard Peripheral Vascular Inc
Aug 2, 2024	BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN161...	Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result...	Class II	Bard Peripheral Vascular Inc
Jul 10, 2024	Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended f...	Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within t...	Class II	Bard Peripheral Vascular Inc
Nov 14, 2023	BD Recanalization System, REF: BDRECANSYSTEM	Recanalization systems may be in a manufacturing mode that allows the system to continuously run ...	Class II	Bard Peripheral Vascular Inc
Nov 8, 2023	Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Missi...	The internal diameter of the coaxial cannula may be smaller or larger than the external diameter ...	Class II	Bard Peripheral Vascular Inc
Aug 10, 2023	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016	Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy i...	Class II	Bard Peripheral Vascular Inc
Apr 11, 2023	Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM;...	Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter a...	Class II	Bard Peripheral Vascular Inc
Feb 28, 2023	Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK;...	The external diameter of the biopsy instrument is larger than the internal diameter of the coaxia...	Class II	Bard Peripheral Vascular Inc
Jan 4, 2023	Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair...	Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).	Class II	Bard Peripheral Vascular Inc
Dec 22, 2022	The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis...	An increase in the reported complaint rate for inability to deploy was identified and related to ...	Class II	Bard Peripheral Vascular Inc
Apr 22, 2022	REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,	There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 F...	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle ...	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	LUMBAR PUNCTURE TRAY ADULT 18G X 3.5	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	LUMBAR PUNCTURE DRUG FREE TRAY 22G	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	SAFE-T PLUS ATRAUMATIC ADULT LP TRAY	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Jan 20, 2022	LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.	Class II	Bard Peripheral Vascular Inc
Aug 24, 2021	Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/...	Due to misbranded products shipped to customers.	Class II	Bard Peripheral Vascular Inc
Aug 24, 2021	Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiratio...	Due to misbranded products shipped to customers.	Class II	Bard Peripheral Vascular Inc
Jul 27, 2021	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle,...	Potential for needle protector to become fully dislodge exposing infusion needle which could resu...	Class II	Bard Peripheral Vascular Inc
Jun 23, 2021	TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79...	Due to complaints received regarding incomplete/open packaging seals potentially causing product ...	Class II	Bard Peripheral Vascular Inc
Jun 23, 2021	EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen C...	Due to complaints received regarding incomplete/open packaging seals potentially causing product ...	Class II	Bard Peripheral Vascular Inc
Jun 23, 2021	TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acqu...	Due to complaints received regarding incomplete/open packaging seals potentially causing product ...	Class II	Bard Peripheral Vascular Inc
Mar 25, 2021	PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-...	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge...	Class II	Bard Peripheral Vascular Inc
Mar 25, 2021	PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-...	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge...	Class II	Bard Peripheral Vascular Inc
Mar 25, 2021	PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-...	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge...	Class II	Bard Peripheral Vascular Inc
Jan 14, 2021	BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm R...	Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy ne...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL1...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Dec 14, 2020	VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14...	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining ...	Class II	Bard Peripheral Vascular Inc
Oct 1, 2020	Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ75...	Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon siz...	Class II	Bard Peripheral Vascular Inc
Mar 17, 2020	Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A...	Sterility compromised due to packaging pouches that may not be sealed properly	Class II	Bard Peripheral Vascular Inc
Jan 15, 2020	BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept...	The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock pe...	Class II	Bard Peripheral Vascular Inc
Jan 3, 2020	Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, package...	Lot numbers and products inadvertently not included in the scope of the previous recall. Origina...	Class II	Bard Peripheral Vascular Inc
Jan 3, 2020	Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged i...	Lot numbers and products inadvertently not included in the scope of the previous recall. Origina...	Class II	Bard Peripheral Vascular Inc
Jan 3, 2020	Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, pack...	Lot numbers and products inadvertently not included in the scope of the previous recall. Origina...	Class II	Bard Peripheral Vascular Inc
Jan 3, 2020	Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged...	Lot numbers and products inadvertently not included in the scope of the previous recall. Origina...	Class II	Bard Peripheral Vascular Inc
Oct 25, 2019	BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core nee...	During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Bi...	Class II	Bard Peripheral Vascular Inc
Oct 1, 2019	1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570...	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b...	Class II	Bard Peripheral Vascular Inc
Oct 1, 2019	1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-...	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b...	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.