ClearanceBrief

Latest device recalls

Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.

DateFirm and productCodeLinked 510(k)
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B
Open, Classified
OJHNone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
Open, Classified
OJGNone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
Open, Classified
LRONone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Open, Classified
OEZNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Open, Classified
OKVNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Open, Classified
LRONone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
Open, Classified
OHDNone listed
Jul 23, 2026Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
Open, Classified
LRONone listed
Jul 23, 2026Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4)
Open, Classified
OJHNone listed
Jul 23, 2026Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Open, Classified
LROK213481
Jul 23, 2026Medtronic MiniMed, Inc.
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Open, Classified
NDCK253512
Jul 23, 2026Karl Storz Endoscopy
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Open, Classified
HIHK961605
Jul 23, 2026Alphatec Spine, Inc.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Open, Classified
GWFK252842
Jul 22, 2026KENT IMAGING, INC.
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
Open, Classified
QJFK242669
Jul 22, 2026Micro Therapeutics, Inc.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Open, Classified
OUTNone listed
Jul 22, 2026Micro Therapeutics, Inc.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Open, Classified
OUTNone listed
Jul 22, 2026Medline Industries, LP
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, M
Open, Classified
OJHK213481
Jul 22, 2026Medline Industries, LP
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Open, Classified
OHMK213481
Jul 22, 2026Medline Industries, LP
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Open, Classified
LROK213481
Jul 22, 2026AVID Medical, Inc.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Open, Classified
OESNone listed
Jul 22, 2026Emano Metrics, Inc.
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volu
Open, Classified
EXYNone listed
Jul 22, 2026Boston Scientific Corporation
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Open, Classified
LLZK252547
K260479
Jul 22, 2026Olympus Corporation of the Americas
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Open, Classified
HIFK243527
Jul 21, 2026Medtronic Neurosurgery
Ventriculostomy Kit, REF: 46154
Open, Classified
HBGK915546
Jul 21, 2026Penumbra, Inc.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Open, Classified
NRYK211411
Jul 21, 2026Wilcox Industries Corp.
The intended use is to be paired with a weapon for aiming purposes.
Open, Classified
REUNone listed
Jul 21, 2026PIE Medical Imaging B.V.
3mensio Workstation (Vascular Fenestrated) software
Open, Classified
QIHK250330
Jul 21, 2026Prismatik Dentalcraft, Inc.
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to t
Open, Classified
LRKK183270
K972424
Jul 20, 2026Olympus Corporation of the Americas
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Open, Classified
GCJK220069
Jul 20, 2026Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
Open, Classified
DRAK233248
Jul 20, 2026Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
Open, Classified
DRAK233248
Jul 20, 2026Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Open, Classified
DRAK233248
Jul 20, 2026Boston Scientific Corporation
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Open, Classified
DRANone listed
Jul 20, 2026AVID Medical, Inc.
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Open, Classified
OJKNone listed
Jul 20, 2026SEASPINE ORTHOPEDICS CORPORATION
SeaSpine Polyaxial Head REF Number: 41-3010
Open, Classified
NKBK173882
Jul 17, 2026Ferno-Washington Inc
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground
Open, Classified
FPONone listed
Jul 17, 2026ICU Medical Inc.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow
Open, Classified
LGZK911383
Jul 17, 2026Paragon 28, Inc.
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Open, Classified
HXINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 17, 2026Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Open, Classified
QZINone listed
Jul 16, 2026Tosoh Bioscience Inc
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Open, Classified
CDZK023091
Jul 15, 2026Daavlin Distributing Company
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Open, Classified
FTCK182215
Jul 15, 2026Daavlin Distributing Company
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Open, Classified
FTCK212510