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 27, 2026GE Medical Systems Information Technologies Inc
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Open, Classified
MWINone listed
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Open, Classified
MWIK230626
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Open, Classified
MWIK234130
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Open, Classified
MWIK234130
Aug 26, 2026Olympus Corporation of the Americas
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Open, Classified
GEIK212643
Aug 26, 2026IMRIS Imaging Inc
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Open, Classified
KXJNone listed
Aug 26, 2026IMRIS Imaging Inc
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Open, Classified
FQONone listed
Aug 26, 2026Healthmark Industries Co., Inc.
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Open, Classified
SDCNone listed
Aug 26, 2026Healthmark Industries Co., Inc.
healthmark ProChek-II, Model Number PT-313, PT-201-12
Open, Classified
SDCNone listed
Aug 26, 2026FUJIFILM Healthcare Americas Corporation
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Open, Classified
LLZK190232
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRA
Open, Classified
OJHNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B;
Open, Classified
OKVNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYS
Open, Classified
OJFNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
Open, Classified
OHMNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4
Open, Classified
OHDNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAV
Open, Classified
LROK213481
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Open, Classified
FTNNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPA
Open, Classified
FDENone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Open, Classified
OGRNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE
Open, Classified
OEZNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Open, Classified
OESNone listed
Aug 26, 2026ConMed Corporation
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
Open, Classified
MAIK101100
Aug 26, 2026Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Open, Classified
KDIK243237
Aug 25, 2026Henry Schein Inc.
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 25390
Open, Classified
EBFK051867
Aug 25, 2026Henry Schein Inc.
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Produc
Open, Classified
EBFK040769
Aug 25, 2026Midmark Corporation
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Open, Classified
DRGK220526
Aug 25, 2026Midmark Corporation
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Open, Classified
DPSK103640
Aug 25, 2026Canon Medical System, USA, INC.
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for
Open, Classified
OWBK182415
K203551 +1
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Open, Classified
LRONone listed
Aug 21, 2026AVID Medical, Inc.
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Open, Classified
LRONone listed
Aug 21, 2026Merge Healthcare, Inc.
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Open, Classified
OEZNone listed
Aug 21, 2026Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Open, Classified
JAKK212441
Aug 21, 2026Medline Industries, LP
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Open, Classified
OFRNone listed
Aug 21, 2026Hollister Ulc
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermi
Open, Classified
GBMK211436
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4)
Open, Classified
OJHNone listed
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF
Open, Classified
OJGNone listed
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYR
Open, Classified
LROK213481
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK,
Open, Classified
OGRNone listed
Aug 21, 2026Medline Industries, LP
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON
Open, Classified
OGGNone listed
Aug 21, 2026Medline Industries, LP
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONAT
Open, Classified
BZOK903083
Aug 21, 2026Medline Industries, LP
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Open, Classified
BTTK031383