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)
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component:
Open, Classified
ITIK042612
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Co
Open, Classified
ITIK042612
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Open, Classified
ITIK011993
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Com
Open, Classified
ITIK112815
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 C
Open, Classified
ITIK143383
Jul 31, 2026Therabody, Inc
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA
Open, Classified
ISANone listed
Jul 31, 2026Beckman Coulter Biomedical GmbH
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Open, Classified
JQPNone listed
Jul 30, 2026Terex Utilities
Power Over Fiber Base Module
Open, Classified
RFNNone listed
Jul 30, 2026Medical Action Industries, Inc. 306
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Open, Classified
OEZNone listed
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified
CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified
CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified
CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified
CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and asses
Open, Classified
CHLK223608
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Open, Classified
KTTK033476
Jul 29, 2026Stryker GmbH
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Open, Classified
KTTK033476
Jul 29, 2026Instrumentation Laboratory
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Read
Open, Classified
CHLK203790
Jul 28, 2026IsoTis OrthoBiologics, Inc.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Open, Classified
MQVK172130
Jul 28, 2026ResMed Ltd.
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventil
Open, Classified
CBKK152068
K172875
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Open, Classified
JAKK160743
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
IQon Spectral CT IQon Spectral CT Upgrades
Open, Classified
JAKK193454
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Open, Classified
JAKK250648
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Open, Classified
OKENone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281
Open, Classified
LRONone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Open, Classified
OJGNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Open, Classified
OESNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Open, Classified
OEQNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part
Open, Classified
OGJNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) N
Open, Classified
OGENone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Open, Classified
OFTNone listed
Jul 27, 2026Medtronic Perfusion Systems
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Open, Classified
DWFK260195
Jul 27, 2026Medtronic Perfusion Systems
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Open, Classified
DWFK260195
Jul 27, 2026Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Open, Classified
DWFK031037
Jul 27, 2026Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Open, Classified
DWFK031037
Jul 27, 2026Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Open, Classified
DWFK031037
Jul 27, 2026Medtronic Perfusion Systems
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Open, Classified
DWFK031037
Jul 24, 2026Argon Medical Devices, Inc
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Open, Classified
LJSK230669
Jul 24, 2026Argon Medical Devices, Inc
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.
Open, Classified
LJSK230669
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4)
Open, Classified
OJHNone listed
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine
Open, Classified
OJGNone listed
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
Open, Classified
OGRNone listed
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pac
Open, Classified
LRONone listed
Jul 24, 2026Permobil Inc
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
Open, Classified
ITIK123290
Jul 24, 2026Permobil Inc
M5 Corpus Power Wheelchair REF,120032
Open, Classified
ITIK123290