Sep 2, 2026
Z-3014-2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography co…
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Sep 2, 2026
Z-3013-2026
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.
Midmark Corporation
- DRG
- Class II
- Ongoing
Sep 2, 2026
Z-3012-2026
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.…
Midmark Corporation
- DPS
- Class II
- Ongoing
Sep 2, 2026
Z-3011-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3010-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3009-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3008-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3007-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3006-2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3005-2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3004-2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Merge Healthcare, Inc.
- LLZ
- Class II
- Ongoing
Sep 2, 2026
Z-3003-2026
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
American Contract Systems Inc
- OEZ
- Class II
- Ongoing
Sep 2, 2026
Z-3002-2026
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
American Contract Systems Inc
- OEZ
- Class II
- Ongoing
Sep 2, 2026
Z-3001-2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
American Contract Systems Inc
- OEZ
- Class II
- Ongoing
Sep 2, 2026
Z-3000-2026
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
American Contract Systems Inc
- OEZ
- Class II
- Ongoing
Sep 2, 2026
Z-2999-2026
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Medline Industries, LP
- OFR
- Class II
- Ongoing
Sep 2, 2026
Z-2998-2026
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch1…
Hollister Ulc
- GBM
- Class II
- Ongoing
Sep 2, 2026
Z-2997-2026
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE P…
Medline Industries, LP
- OJH
- Class II
- Ongoing
Sep 2, 2026
Z-2996-2026
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…
Medline Industries, LP
- OJG
- Class II
- Ongoing
Sep 2, 2026
Z-2995-2026
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 Industries, LP
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-2994-2026
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…
Medline Industries, LP
- OGR
- Class II
- Ongoing
Sep 2, 2026
Z-2993-2026
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Num…
Medline Industries, LP
- OGG
- Class II
- Ongoing
Sep 2, 2026
Z-2992-2026
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07);…
Medline Industries, LP
- BZO
- Class II
- Ongoing
Sep 2, 2026
Z-2991-2026
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respi…
Medline Industries, LP
- BTT
- Class II
- Ongoing
Sep 2, 2026
Z-2988-2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Philips Healthcare (Suzhou) Co., Ltd.
- JAK
- Class II
- Ongoing