Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 27, 2026 Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delive... The implantable clip may experience difficulties deploying, which could prevent the reflector fro... Class II Merit Medical Systems, Inc.
Aug 27, 2026 Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an... While in the high-power operating mode, a video dropout/blackout may occur when using a particula... Class II Olympus Corporation of the Americas
Aug 20, 2026 CADD Yellow Medication Cassette Reservoir with NRFit connector US Product ... Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue c... Class II ICU Medical, Inc.
Aug 19, 2026 Presource Packs containing Medtronic Microstream Components: Intubation Ki... Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of th... Class II Cardinal Health 200, LLC
Aug 18, 2026 BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-... Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight se... Class II Stryker Sustainability Solutions
Aug 12, 2026 Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Join... Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... Class II BioFire Diagnostics, LLC
Aug 12, 2026 Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue c... Medtronic identified through donor record review that the donor for Medtronic batch A62881 did n... Class II Medtronic Sofamor Danek USA Inc
Aug 12, 2026 Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue co... Medtronic identified through donor record review that the donor for Medtronic batch A62881 did no... Class II Medtronic Sofamor Danek USA Inc
Aug 10, 2026 Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... Class II Cardinal Health 200, LLC
Aug 6, 2026 Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex M... Wheels may come loose when module is being pushed or pulled during movement or transportation, af... Class II Heidelberg Engineering GmbH
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 30, 2026 BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... Class I Bard Access Systems, Inc.
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 13, 2026 GM Helix Implant, Endosseous Dental Implant Article No. 109.984 There may be a mismatch between the implant contained inside the packaging and the information de... Class II Straumann USA LLC
Jul 10, 2026 Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Cat... Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... Class III Paragon 28, Inc.
Jul 10, 2026 Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catal... Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... Class III Paragon 28, Inc.
Jun 30, 2026 Rapid Refill Continuous Injection System, UPN M00566001 Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... Class II Boston Scientific Corporation
Jun 24, 2026 Hotline Fluid Warming Set, single use device, is designed to warm blood and i... ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE F... Class II ICU Medical Inc.
Jun 17, 2026 Ventriculostomy Kit, REF: 46154 Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... Class II Medtronic Neurosurgery
Jun 12, 2026 Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2)... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC0... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CD... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) P... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS8600... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG D... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM14... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYN... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 10, 2026 Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infus... In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... Class II ICU Medical, Inc.
Jun 10, 2026 ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) ... In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... Class II ICU Medical, Inc.
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
Jun 8, 2026 MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I Medline Industries, LP
May 25, 2026 Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardio... Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... Class II Medtronic Perfusion Systems
May 22, 2026 IntelliCuff, Portable automatic cuff pressure controller REF: 951001 Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a re... Class II Hamilton Medical AG

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.