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 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Open, Classified
GGNNone listed
Aug 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Open, Classified
JIXNone listed
Aug 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Open, Classified
JITNone listed
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 7220
Open, Classified
OWBK102005
K130638 +3
Aug 5, 2026Hardy Diagnostics
HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the suscepti
Open, Classified
JTNK253105
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgica
Open, Classified
LXHNone listed
Aug 5, 2026United Orthopedic Corp.
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A P
Open, Classified
KROK190100
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Produ
Open, Classified
JWHK082424
Aug 5, 2026Boston Scientific Neuromodulation Corporation
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (
Open, Classified
LGWNone listed
Aug 4, 2026GE Medical Systems Information Technologies Inc
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Open, Classified
MWIK234130
Aug 4, 2026Biofire Defense
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for
Open, Classified
PRDK170883
Aug 4, 2026GE Medical Systems Information Technologies Inc
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Open, Classified
DPSK173830
Aug 4, 2026Merge Healthcare, Inc.
Merge OrthoPACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Aug 4, 2026Merge Healthcare, Inc.
Merge PACS, medical imaging diagnostic workstation
Open, Classified
LLZK192455
Aug 4, 2026Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Open, Classified
LFGK821743
Aug 4, 2026Siemens Healthcare Diagnostics, Inc.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Open, Classified
KLRK801204
Aug 4, 2026Happiest Baby, Inc
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Open, Classified
QTGNone listed
Aug 3, 2026Nuclein LLC
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH Rapid PCR Instrument (DASH Instrument)
Open, Classified
NSUK241652
Aug 3, 2026Maquet Critical Care AB
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Open, Classified
BSZK191027
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Open, Classified
LXHNone listed
Aug 3, 2026Stryker Corporation
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Open, Classified
GEIK963646
Aug 3, 2026Stryker Corporation
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Open, Classified
GEIK963646
Aug 3, 2026Stryker Corporation
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Open, Classified
GCXK042454
Aug 3, 2026Stryker Corporation
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Open, Classified
GCXK042454
Aug 3, 2026Stryker Corporation
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Open, Classified
GCXK042454
Aug 3, 2026Medical Action Industries, Inc. 306
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Open, Classified
PEVNone listed
Aug 3, 2026Oxos Medical Inc
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2
Open, Classified
OWBK252068
Aug 3, 2026Innovasis, Inc
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Open, Classified
NKBK241276
K250182 +1
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Open, Classified
OEZNone listed
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Open, Classified
OESNone listed
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
Open, Classified
OESNone listed
Jul 31, 2026MUNEVO GMBH
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Open, Classified
KNNNone listed
Jul 31, 2026INTEGRATED MEDCRAFT LLC
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5,
Open, Classified
OHONone listed
Jul 31, 2026THERANICA BIOELECTRONICS LTD
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Open, Classified
QGTK250405
Jul 31, 2026Boston Scientific Corporation
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Open, Classified
FCLNone listed
Jul 31, 2026Boston Scientific Corporation
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm
Open, Classified
FCLNone listed
Jul 31, 2026Boston Scientific Corporation
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240c
Open, Classified
FCLNone listed
Jul 31, 2026Copan WASP
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used
Open, Classified
JQPNone listed
Jul 31, 2026INTEGRATED MEDCRAFT LLC
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050.
Open, Classified
CAENone listed
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Compone
Open, Classified
ITIK011993
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.38
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Cont
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Cont
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 89
Open, Classified
ITIK143383
Jul 31, 2026Pride Mobility Products Corp.
Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component
Open, Classified
ITIK112815