Latest device recalls
Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2026 | Medline 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 |
OJH | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline medical convenience kits labeled as:
NEURO PACK, Medline Kit SKU DYNJ59397P Open, Classified |
OJG | None listed |
| Jul 23, 2026 | Medline 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 |
LRO | None listed |
| Jul 23, 2026 | Medline 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 |
OEZ | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
SM-LAPAROSCOPIC PROSTATE PAC
DYNJ61206J Open, Classified |
OHD | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
RR-DAVINCI PROSTATE ACCESSORY
DYNJ63392F Open, Classified |
OHD | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
ROBOTIC
CDS980523M Open, Classified |
OHD | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
PROSTATE ROBOTIC
DYNJ901822B Open, Classified |
OHD | None listed |
| Jul 23, 2026 | Medline 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 |
OHD | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
UROLOGY ROBOTIC PROCEDURE PACK
DYNJ0945779U Open, Classified |
LRO | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
DAVINCI PROSTATE PACK
DYNJ68477L
DYNJ68477M Open, Classified |
OHD | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116I Open, Classified |
LRO | None listed |
| Jul 23, 2026 | Medline 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 |
OJH | None listed |
| Jul 23, 2026 | Medline Industries, LP MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N Open, Classified |
LRO | K213481 |
| Jul 23, 2026 | Medtronic MiniMed, Inc. MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) Open, Classified |
NDC | K253512 |
| Jul 23, 2026 | Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. Open, Classified |
HIH | K961605 |
| Jul 23, 2026 | Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Open, Classified |
GWF | K252842 |
| Jul 22, 2026 | KENT IMAGING, INC. SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. Open, Classified |
QJF | K242669 |
| Jul 22, 2026 | Micro 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 |
OUT | None listed |
| Jul 22, 2026 | Micro 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 |
OUT | None listed |
| Jul 22, 2026 | Medline 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 |
OJH | K213481 |
| Jul 22, 2026 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) C-SECTION, Medline SKU DYNJ910835;
2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits Open, Classified |
OHM | K213481 |
| Jul 22, 2026 | Medline Industries, LP MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G Open, Classified |
LRO | K213481 |
| Jul 22, 2026 | AVID Medical, Inc. Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01.
Convenience kit. Open, Classified |
OES | None listed |
| Jul 22, 2026 | Emano 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 |
EXY | None listed |
| Jul 22, 2026 | Boston Scientific Corporation Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. Open, Classified |
LLZ | K252547 K260479 |
| Jul 22, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Open, Classified |
HIF | K243527 |
| Jul 21, 2026 | Medtronic Neurosurgery Ventriculostomy Kit, REF: 46154 Open, Classified |
HBG | K915546 |
| Jul 21, 2026 | Penumbra, Inc. Penumbra System RED 68 Reperfusion Catheter
REF: RED68KIT Open, Classified |
NRY | K211411 |
| Jul 21, 2026 | Wilcox Industries Corp. The intended use is to be paired with a weapon for aiming purposes. Open, Classified |
REU | None listed |
| Jul 21, 2026 | PIE Medical Imaging B.V. 3mensio Workstation (Vascular Fenestrated) software Open, Classified |
QIH | K250330 |
| Jul 21, 2026 | Prismatik 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 |
LRK | K183270 K972424 |
| Jul 20, 2026 | Olympus 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 |
GCJ | K220069 |
| Jul 20, 2026 | Boston 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 |
DRA | K233248 |
| Jul 20, 2026 | Boston 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 |
DRA | K233248 |
| Jul 20, 2026 | Boston 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 |
DRA | K233248 |
| Jul 20, 2026 | Boston 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 |
DRA | None listed |
| Jul 20, 2026 | AVID Medical, Inc. Halyard EYE PACK. Model/Catalog Number: LVEY27
Convenience kit. Open, Classified |
OJK | None listed |
| Jul 20, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Polyaxial Head
REF Number: 41-3010 Open, Classified |
NKB | K173882 |
| Jul 17, 2026 | Ferno-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 |
FPO | None listed |
| Jul 17, 2026 | ICU 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 |
LGZ | K911383 |
| Jul 17, 2026 | Paragon 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 |
HXI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 16, 2026 | Tosoh 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 |
CDZ | K023091 |
| Jul 15, 2026 | Daavlin Distributing Company Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified |
FTC | K182215 |
| Jul 15, 2026 | Daavlin Distributing Company Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Open, Classified |
FTC | K212510 |