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) |
|---|---|---|---|
| Aug 20, 2026 | American 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 |
OJH | None listed |
| Aug 20, 2026 | American 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 |
OJG | None listed |
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter Open, Classified |
NTE | K230402 |
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter Open, Classified |
NTE | K153485 |
| Aug 19, 2026 | ConvaTec, 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 |
EXG | None listed |
| Aug 19, 2026 | BMC Medical Co., Ltd. BMC/REACTHEALTH
Luna G3 APAP
REF LG 3600 Open, Classified |
MNS | None listed |
| Aug 19, 2026 | restor3d 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 |
PHX | K243643 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW Open, Classified |
QFG | K251032 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; Open, Classified |
OZP | None listed |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; Open, Classified |
QFG | K251032 |
| Aug 18, 2026 | Fort Defiance Industries, LLC Fort Defiance Industries (FDI), Automated Field Steam Sterilizer
REF: P2131 Open, Classified |
FLE | K141009 |
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Beckman Coulter, Emit 2000 Quinidine Assay
REF: OSR4Q229
Contents: R1: 2 x 23 mL;R2 2x13 mL Open, Classified |
LBZ | K011605 |
| Aug 17, 2026 | Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay
REF: 4Q019UL
Contents: 1x28 mL, 1x14mL Open, Classified |
LBZ | K922913 |
| Aug 17, 2026 | Beckman 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 |
JJE | K220977 |
| Aug 17, 2026 | Beckman 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 |
JJE | K242190 |
| Aug 14, 2026 | Spectral Instruments Inc Ami HTX Open, Classified |
RCE | None listed |
| Aug 14, 2026 | Spectral Instruments Inc Lago X Open, Classified |
RCE | None listed |
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 7000. Product Number: 860441. Open, Classified |
DPS | K241556 |
| Aug 14, 2026 | Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant Open, Classified |
PLF | None listed |
| Aug 14, 2026 | Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant Open, Classified |
PLF | None listed |
| Aug 14, 2026 | Bard 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 |
FMI | K191976 K203193 |
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol III, Model 233; Thermal regulating system. Open, Classified |
DWJ | K101589 |
| Aug 14, 2026 | Gentherm Medical, LLC Innercool Coolblue Console, Model STx; Thermal regulating system. Open, Classified |
DWJ | K101589 |
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol II Model 222S; Thermal regulating system. Open, Classified |
DWJ | K110104 |
| Aug 14, 2026 | Paragonix Technologies Inc. Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System
REF# PRGNX-8008-001 Open, Classified |
KDN | K234060 |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF(s):L2kSY2/10489085; L2KSY6/10488319
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF:L2KSY2(D)/10471981
IVD, RxOnly Open, Classified |
LIP | K091361 |
| Aug 14, 2026 | AVID Medical, Inc. Halyard LAVH PACK, Model/Catalog Number: USAR053-11 Open, Classified |
OKV | None listed |
| Aug 14, 2026 | Maquet Critical Care AB GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use Open, Classified |
CBK | K201874 |
| Aug 14, 2026 | Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | K181141 K201808 |
| Aug 14, 2026 | Boston Scientific Corporation OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | K181141 K201808 |
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Maxi Speech Generating Device
Model/Catalog Number: 1000799 Open, Classified |
ILQ | None listed |
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Midi Speech Generating Device
Model/Catalog Number: 1000798 Open, Classified |
ILQ | None listed |
| Aug 14, 2026 | Arrowhead 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 |
HTY | K112675 |
| Aug 14, 2026 | Kico 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 |
SBF | K243950 K243980 |
| Aug 14, 2026 | Philips North America Llc Cardiac Workstation 5000. Product Number: 860439. Open, Classified |
DPS | K241556 |
| Aug 14, 2026 | SDI Limited Dentsply Sirona Capsule Mixer
Model No. 5546068 Open, Classified |
EFD | None listed |
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Aug 14, 2026 | Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. Open, Classified |
PQP | None listed |
| Aug 14, 2026 | Covidien, 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 |
FFX | K183072 |
| Aug 13, 2026 | Cardinal 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 |
OJK | None listed |
| Aug 13, 2026 | Cardinal 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 |
OJH | None listed |
| Aug 13, 2026 | Cardinal 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 |
OJG | None listed |
| Aug 13, 2026 | Cardinal 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 |
OJA | None listed |
| Aug 13, 2026 | Cardinal 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 |
OGR | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB Open, Classified |
OEZ | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC Open, Classified |
OFQ | None listed |
| Aug 13, 2026 | Cardinal 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 |
LRO | None listed |
| Aug 13, 2026 | BD 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 |
FPA | K051499 K083472 |