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)
Aug 20, 2026American Contract Systems Inc
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
Open, Classified
OJHNone listed
Aug 20, 2026American Contract Systems Inc
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Mode
Open, Classified
OJGNone listed
Aug 20, 2026Boston Scientific Corporation
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Open, Classified
NTEK230402
Aug 20, 2026Boston Scientific Corporation
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Open, Classified
NTEK153485
Aug 19, 2026ConvaTec, Inc
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 42
Open, Classified
EXGNone listed
Aug 19, 2026BMC Medical Co., Ltd.
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Open, Classified
MNSNone listed
Aug 19, 2026restor3d Inc.
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product P
Open, Classified
PHXK243643
Aug 18, 2026Medtronic MiniMed, Inc.
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Open, Classified
QFGK251032
Aug 18, 2026Medtronic MiniMed, Inc.
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Open, Classified
OZPNone listed
Aug 18, 2026Medtronic MiniMed, Inc.
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Open, Classified
QFGK251032
Aug 18, 2026Fort Defiance Industries, LLC
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Open, Classified
FLEK141009
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Open, Classified
LBZK011605
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Open, Classified
LBZK922913
Aug 17, 2026Beckman Coulter Inc.
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyze
Open, Classified
JJEK220977
Aug 17, 2026Beckman Coulter Inc.
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521;
Open, Classified
JJEK242190
Aug 14, 2026Spectral Instruments Inc
Ami HTX
Open, Classified
RCENone listed
Aug 14, 2026Spectral Instruments Inc
Lago X
Open, Classified
RCENone listed
Aug 14, 2026Philips North America Llc
Cardiac Workstation 7000. Product Number: 860441.
Open, Classified
DPSK241556
Aug 14, 2026Paragon 28, Inc.
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Open, Classified
PLFNone listed
Aug 14, 2026Paragon 28, Inc.
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Open, Classified
PLFNone listed
Aug 14, 2026Bard Access Systems, Inc.
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit
Open, Classified
FMIK191976
K203193
Aug 14, 2026Gentherm Medical, LLC
Blanketrol III, Model 233; Thermal regulating system.
Open, Classified
DWJK101589
Aug 14, 2026Gentherm Medical, LLC
Innercool Coolblue Console, Model STx; Thermal regulating system.
Open, Classified
DWJK101589
Aug 14, 2026Gentherm Medical, LLC
Blanketrol II Model 222S; Thermal regulating system.
Open, Classified
DWJK110104
Aug 14, 2026Paragonix Technologies Inc.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Open, Classified
KDNK234060
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Open, Classified
LIPK091361
Aug 14, 2026Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Open, Classified
LIPK091361
Aug 14, 2026AVID Medical, Inc.
Halyard LAVH PACK, Model/Catalog Number: USAR053-11
Open, Classified
OKVNone listed
Aug 14, 2026Maquet Critical Care AB
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Open, Classified
CBKK201874
Aug 14, 2026Boston Scientific Corporation
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Open, Classified
OCWK181141
K201808
Aug 14, 2026Boston Scientific Corporation
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Open, Classified
OCWK181141
K201808
Aug 14, 2026Tobii Dynavox Llc
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Open, Classified
ILQNone listed
Aug 14, 2026Tobii Dynavox Llc
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Open, Classified
ILQNone listed
Aug 14, 2026Arrowhead DE LLC
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528,
Open, Classified
HTYK112675
Aug 14, 2026Kico Knee Innovation Company
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS S
Open, Classified
SBFK243950
K243980
Aug 14, 2026Philips North America Llc
Cardiac Workstation 5000. Product Number: 860439.
Open, Classified
DPSK241556
Aug 14, 2026SDI Limited
Dentsply Sirona Capsule Mixer Model No. 5546068
Open, Classified
EFDNone listed
Aug 14, 2026Intersurgical Inc
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Open, Classified
CAENone listed
Aug 14, 2026Intersurgical Inc
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Open, Classified
CAENone listed
Aug 14, 2026Foundation Medicine, Inc.
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Open, Classified
PQPNone listed
Aug 14, 2026Covidien, LLC
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
Open, Classified
FFXK183072
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catal
Open, Classified
OJKNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog
Open, Classified
OJHNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catal
Open, Classified
OJGNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catal
Open, Classified
OJANone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog
Open, Classified
OGRNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Open, Classified
OEZNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Open, Classified
OFQNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog N
Open, Classified
LRONone listed
Aug 13, 2026BD SWITZERLAND SARL
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-
Open, Classified
FPAK051499
K083472