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 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Control, Model Number 5D-44905 Open, Classified |
GGN | None listed |
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Open, Classified |
JIX | None listed |
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 Open, Classified |
JIT | None listed |
| Aug 5, 2026 | PHILIPS 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 |
OWB | K102005 K130638 +3 |
| Aug 5, 2026 | Hardy 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 |
JTN | K253105 |
| Aug 5, 2026 | United 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 |
LXH | None listed |
| Aug 5, 2026 | United 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 |
KRO | K190100 |
| Aug 5, 2026 | United 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 |
JWH | K082424 |
| Aug 5, 2026 | Boston 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 |
LGW | None listed |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 Open, Classified |
MWI | K234130 |
| Aug 4, 2026 | Biofire 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 |
PRD | K170883 |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph Open, Classified |
DPS | K173830 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge OrthoPACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Merge Healthcare, Inc. Merge PACS, medical imaging diagnostic workstation Open, Classified |
LLZ | K192455 |
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls
SMN 10445390
Catalog No. 7C219UL Open, Classified |
LFG | K821743 |
| Aug 4, 2026 | Siemens Healthcare Diagnostics, Inc. Syva Emit Disopyramide Assay
Enzyme Immunoassay, Lidocaine
SMN 10445370
Catalog No 6N319UL Open, Classified |
KLR | K801204 |
| Aug 4, 2026 | Happiest Baby, Inc Happiest Baby, Inc
Pre-loved SNOO Smart Sleeper
Model:S1000 Open, Classified |
QTG | None listed |
| Aug 3, 2026 | Nuclein 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 |
NSU | K241652 |
| Aug 3, 2026 | Maquet 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 |
BSZ | K191027 |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475640
Product Description: Intramedullary Bone Saw Blade Assembly 16mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475635
Product Description: Intramedullary Bone Saw Blade Assembly 15mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475630
Product Description: Intramedullary Bone Saw Blade Assembly 14mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475625
Product Description: Intramedullary Bone Saw Blade Assembly 13mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475620
Product Description: Intramedullary Bone Saw Blade Assembly 12mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 Open, Classified |
GEI | K963646 |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 Open, Classified |
GEI | K963646 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 Open, Classified |
GCX | K042454 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 Open, Classified |
GCX | K042454 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 Open, Classified |
GCX | K042454 |
| Aug 3, 2026 | Medical Action Industries, Inc. 306 Brand Name: Medical Action Industries
Product Name: Dialysis Change Tray Clear Sequence
Model/Catalog Number: 78791 Open, Classified |
PEV | None listed |
| Aug 3, 2026 | Oxos 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 |
OWB | K252068 |
| Aug 3, 2026 | Innovasis, Inc Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System Open, Classified |
NKB | K241276 K250182 +1 |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
HEART CATH, SELF REGIONAL
SELF131-05 Open, Classified |
OEZ | None listed |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
SAMMC ANGIOGRAPHY
SAMM066-15 Open, Classified |
OES | None listed |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
CARDIAC CATH PACK EAMC1000-05 Open, Classified |
OES | None listed |
| Jul 31, 2026 | MUNEVO GMBH munevo DRIVE and munevo DRIVE r-net
Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System Open, Classified |
KNN | None listed |
| Jul 31, 2026 | INTEGRATED 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 |
OHO | None listed |
| Jul 31, 2026 | THERANICA BIOELECTRONICS LTD Nerivio Infinity. Model/Catalog Number: FGD000100.
Software Version: FW Version 4.1.2.0, App version 7.28.0.11 Open, Classified |
QGT | K250405 |
| Jul 31, 2026 | Boston 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 |
FCL | None listed |
| Jul 31, 2026 | Boston 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 |
FCL | None listed |
| Jul 31, 2026 | Boston 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 |
FCL | None listed |
| Jul 31, 2026 | Copan 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 |
JQP | None listed |
| Jul 31, 2026 | INTEGRATED 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 |
CAE | None listed |
| Jul 31, 2026 | Pride 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 |
ITI | K011993 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K143383 |
| Jul 31, 2026 | Pride 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 |
ITI | K112815 |