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 27, 2026 | GE Medical Systems Information Technologies Inc FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 Open, Classified |
MWI | None listed |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Open, Classified |
MWI | K230626 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Open, Classified |
MWI | K234130 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Open, Classified |
MWI | K234130 |
| Aug 26, 2026 | Olympus 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 |
GEI | K212643 |
| Aug 26, 2026 | IMRIS Imaging Inc ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 Open, Classified |
KXJ | None listed |
| Aug 26, 2026 | IMRIS 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 |
FQO | None listed |
| Aug 26, 2026 | Healthmark Industries Co., Inc. healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 Open, Classified |
SDC | None listed |
| Aug 26, 2026 | Healthmark Industries Co., Inc. healthmark ProChek-II, Model Number PT-313, PT-201-12 Open, Classified |
SDC | None listed |
| Aug 26, 2026 | FUJIFILM Healthcare Americas Corporation FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Open, Classified |
LLZ | K190232 |
| Aug 26, 2026 | Medline 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 |
OJH | None listed |
| Aug 26, 2026 | Medline 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 |
OKV | None listed |
| Aug 26, 2026 | Medline 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 |
OJF | None listed |
| Aug 26, 2026 | Medline 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 |
OHM | None listed |
| Aug 26, 2026 | Medline 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 |
OHD | None listed |
| Aug 26, 2026 | Medline 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 |
LRO | K213481 |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M Open, Classified |
FTN | None listed |
| Aug 26, 2026 | Medline 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 |
FDE | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S Open, Classified |
OGR | None listed |
| Aug 26, 2026 | Medline 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 |
OEZ | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) FEMORAL PACK, Medline Kit SKU DYNJ909393A;
2) FEVAR, Medline Kit SKU DYNJ910295D. Open, Classified |
OES | None listed |
| Aug 26, 2026 | ConMed 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 |
MAI | K101100 |
| Aug 26, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. Open, Classified |
KDI | K243237 |
| Aug 25, 2026 | Henry 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 |
EBF | K051867 |
| Aug 25, 2026 | Henry 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 |
EBF | K040769 |
| Aug 25, 2026 | Midmark 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 |
DRG | K220526 |
| Aug 25, 2026 | Midmark 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 |
DPS | K103640 |
| Aug 25, 2026 | Canon 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 |
OWB | K182415 K203551 +1 |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Halyard TOTAL JOINT
Model/Catalog Number: MSBM036-03 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | AVID Medical, Inc. Brand Name: Halyard
Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK
Model/Catalog Number: SAMM064-27 Open, Classified |
LRO | None listed |
| Aug 21, 2026 | Merge Healthcare, Inc. Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. Open, Classified |
JAK | K212441 |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330 Open, Classified |
OFR | None listed |
| Aug 21, 2026 | Hollister 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 |
GBM | K211436 |
| Aug 21, 2026 | Medline 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 |
OJH | None listed |
| Aug 21, 2026 | Medline 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 |
OJG | None listed |
| Aug 21, 2026 | Medline 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 |
LRO | K213481 |
| Aug 21, 2026 | Medline 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 |
OGR | None listed |
| Aug 21, 2026 | Medline 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 |
OGG | None listed |
| Aug 21, 2026 | Medline 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 |
BZO | K903083 |
| Aug 21, 2026 | Medline 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 |
BTT | K031383 |