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) |
|---|---|---|---|
| Jul 31, 2026 | Pride 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 |
ITI | K042612 |
| Jul 31, 2026 | Pride 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 |
ITI | K042612 |
| Jul 31, 2026 | Pride 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 |
ITI | K011993 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K112815 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Therabody, 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 |
ISA | None listed |
| Jul 31, 2026 | Beckman 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 |
JQP | None listed |
| Jul 30, 2026 | Terex Utilities Power Over Fiber Base Module Open, Classified |
RFN | None listed |
| Jul 30, 2026 | Medical Action Industries, Inc. 306 Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds Open, Classified |
OEZ | None listed |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation Laboratory Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
portable blood analyzer system Open, Classified |
CHL | K203790 |
| Jul 29, 2026 | Instrumentation 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 |
CHL | K223608 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Instrumentation 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 |
CHL | K203790 |
| Jul 28, 2026 | IsoTis 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 |
MQV | K172130 |
| Jul 28, 2026 | ResMed 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 |
CBK | K152068 K172875 |
| Jul 27, 2026 | PHILIPS 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 |
JAK | K160743 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS IQon Spectral CT
IQon Spectral CT Upgrades Open, Classified |
JAK | K193454 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Brilliance iCT
Brilliance iCT Upgrades
Brilliance iCT SP
Brilliance CT 64 Channel
CT6000
Brilliance 64 Upgrades Open, Classified |
JAK | K250648 |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 Open, Classified |
OKE | None listed |
| Jul 27, 2026 | Windstone 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 |
LRO | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414 Open, Classified |
OJG | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B Open, Classified |
OES | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 Open, Classified |
OEQ | None listed |
| Jul 27, 2026 | Windstone 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 |
OGJ | None listed |
| Jul 27, 2026 | Windstone 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 |
OGE | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A Open, Classified |
OFT | None listed |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 Open, Classified |
DWF | K260195 |
| Jul 27, 2026 | Medtronic 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 |
DWF | K260195 |
| Jul 27, 2026 | Medtronic 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 |
DWF | K031037 |
| Jul 27, 2026 | Medtronic 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 |
DWF | K031037 |
| Jul 27, 2026 | Medtronic 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 |
DWF | K031037 |
| Jul 27, 2026 | Medtronic 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 |
DWF | K031037 |
| Jul 24, 2026 | Argon Medical Devices, Inc L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 Open, Classified |
LJS | K230669 |
| Jul 24, 2026 | Argon 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 |
LJS | K230669 |
| Jul 24, 2026 | Windstone 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 |
OJH | None listed |
| Jul 24, 2026 | Windstone 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 |
OJG | None listed |
| Jul 24, 2026 | Windstone 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 |
OGR | None listed |
| Jul 24, 2026 | Windstone 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 |
LRO | None listed |
| Jul 24, 2026 | Permobil Inc Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock
REF:120031, Model version 3 Open, Classified |
ITI | K123290 |
| Jul 24, 2026 | Permobil Inc M5 Corpus Power Wheelchair REF,120032 Open, Classified |
ITI | K123290 |