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) |
|---|---|---|---|
| Oct 15, 2026 | Howmedica Osteonics Corp. TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. Open, Classified |
FSM | None listed |
| Oct 15, 2026 | Cook Incorporated Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 Open, Classified |
FBK | K171602 |
| Oct 15, 2026 | Beckman Coulter, Inc. IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997;
IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684;
IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899 Open, Classified |
KQO | K022774 K210127 +1 |
| Oct 15, 2026 | Beckman Coulter, Inc. DxU 840m Iris, REF: C76947;
DxU 850m Iris, REF: C49513 Open, Classified |
KQO | K022774 K210127 +1 |
| Oct 15, 2026 | Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. Open, Classified |
DOF | K052549 |
| Oct 15, 2026 | Radiometer Medical ApS The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point Open, Classified |
CHL | K041874 |
| Oct 15, 2026 | Microgenics Corporation MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF:
OPRO-101;
MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP Open, Classified |
JJY | None listed |
| Oct 14, 2026 | W L Gore & Associates, Inc. Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;
Model/Catalog Number: VSWVH0808 and VSWVN1006
Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-ex Open, Classified |
FGE | K170740 |
| Oct 14, 2026 | In2bones USA, LLC REF: P65 ST862
CoLag SCREW, FT, 6.7X62.5 mm Open, Classified |
HWC | K170518 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Ethicon, LLC PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H Open, Classified |
GAQ | K946173 |
| Oct 13, 2026 | Baxter Healthcare Corporation Likorall Overhead Lifts
Product Code: 3121001
Product Description: LIKORALL 200
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122005NA
Product Description: LIKO Open, Classified |
FSA | None listed |
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: BioFire Joint Infection (JI) Panel
Generic Name: BioFire Joint Infection (JI) Panel
Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit)
Software Version: N/A
Product Desc Open, Classified |
QSN | None listed |
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel plus
Generic Name: FilmArray Pneumonia Panel plus
Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
Software Version: N/A
Product Description: Open, Classified |
QDS | K243222 |
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel
Generic Name: FilmArray Pneumonia Panel
Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification k Open, Classified |
QDP | K243222 |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) Open, Classified |
LCO | K170854 |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Open, Classified |
LCO | K170854 |
| Oct 9, 2026 | INTEGRATED MEDCRAFT LLC FORWARD Gunshot Wound Kit;
Model: AFT-GSW; Open, Classified |
OHO | None listed |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-306. Catalog Number: 449292. Open, Classified |
LON | K181665 |
| Oct 9, 2026 | SI-BONE, Inc. iFuse TORQ Implant System
Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) Open, Classified |
OUR | K203247 |
| Oct 9, 2026 | Ferno-Washington Inc Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821 Open, Classified |
FPO | None listed |
| Oct 9, 2026 | Sarnova HC, Llc Curaplex Capnography
EtCO2/O2 Oral/Nasal Cannula
Multipack (10 pk), Item Number
670272-KIT Open, Classified |
CCX | None listed |
| Oct 9, 2026 | Boston Scientific Corporation NaviFlex LW Pusher;
Advx Panc. Stent 4/5F;
Material Number (UPN): M00535030; Open, Classified |
FGE | K223592 |
| Oct 9, 2026 | Neuronetics, Inc. NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:
1. NeuroStar 2.0 US; Part Number: 81-01315-0 Open, Classified |
OBP | K231926 K233621 |
| Oct 9, 2026 | Cadwell Industries Inc Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low Open, Classified |
GWF | K162199 |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-312. Catalog Number: 449082. Open, Classified |
LON | K181665 |
| Oct 9, 2026 | Medtronic Sofamor Danek USA Inc Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical for Open, Classified |
MBP | K051188 K051195 |
| Oct 9, 2026 | Medtronic Sofamor Danek USA Inc Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical f Open, Classified |
MBP | K042707 K043048 |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 27MM
REF: TRILOGY-DC-L Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 25MM
REF: TRILOGY-DC-M Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 23MM
REF: TRILOGY-DC-S Open, Classified |
NPT | None listed |
| Oct 7, 2026 | Steris Corporation HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 Open, Classified |
FTA | None listed |
| Oct 7, 2026 | LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter;
Catalog Number: E1651-88; Open, Classified |
DXE | K022145 |
| Oct 7, 2026 | Mindray DS USA, Inc. T1 Patient Monitor. Operator's Manual: T1 Patient Monitor Open, Classified |
MHX | K190011 |
| Oct 7, 2026 | Mindray DS USA, Inc. cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 Open, Classified |
MHX | K153448 |
| Oct 7, 2026 | Mindray DS USA, Inc. Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V Open, Classified |
MHX | K153448 K190011 |
| Oct 7, 2026 | Mindray DS USA, Inc. BeneView Series. Operator's Manuals: T5 / T8 Open, Classified |
MHX | K092449 |
| Oct 7, 2026 | Mindray DS USA, Inc. Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). Open, Classified |
MSX | K242728 |
| Oct 7, 2026 | Mindray DS USA, Inc. BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 Open, Classified |
MSX | K242728 |
| Oct 7, 2026 | Mindray DS USA, Inc. BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. Open, Classified |
MHX | K213799 |
| Oct 7, 2026 | Mindray DS USA, Inc. ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A Open, Classified |
MHX | K260098 |
| Oct 7, 2026 | Intellijoint Surgical, Inc. Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249 Open, Classified |
OLO | K191507 |
| Oct 7, 2026 | AVID Medical, Inc. ABD HYSTERECTOMY;
Model/Item Number (Kit): NAMC438-07; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. GYN LAPAROSCOPY PACK;
Model/Item Number (Kit): NAMC436-12; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. MAJOR PACK;
Model/Item Number (Kit): NIHB0018-11; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. UROLOGY MAJOR;
Model/Item Number (Kit): WRNM058-10; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. HEART PREP TRAY;
Model/Item Number (Kit): MECV97W; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. DAVINCI LAP/GYN;
Model/Item Number (Kit): WRNM037-16; Open, Classified |
OKV | None listed |