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)
Oct 15, 2026Howmedica Osteonics Corp.
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Open, Classified
FSMNone listed
Oct 15, 2026Cook 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
FBKK171602
Oct 15, 2026Beckman 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
KQOK022774
K210127 +1
Oct 15, 2026Beckman Coulter, Inc.
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Open, Classified
KQOK022774
K210127 +1
Oct 15, 2026Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Open, Classified
DOFK052549
Oct 15, 2026Radiometer 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
CHLK041874
Oct 15, 2026Microgenics 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
JJYNone listed
Oct 14, 2026W 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
FGEK170740
Oct 14, 2026In2bones USA, LLC
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Open, Classified
HWCK170518
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Open, Classified
FEBK082988
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Open, Classified
FEBK082988
Oct 14, 2026Steris Corporation
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Open, Classified
FEBK082988
Oct 14, 2026Ethicon, LLC
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Open, Classified
GAQK946173
Oct 13, 2026Baxter 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
FSANone listed
Oct 13, 2026BioFire 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
QSNNone listed
Oct 13, 2026BioFire 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
QDSK243222
Oct 13, 2026BioFire 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
QDPK243222
Oct 10, 2026Instrumentation Laboratory
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Open, Classified
LCOK170854
Oct 10, 2026Instrumentation Laboratory
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Open, Classified
LCOK170854
Oct 9, 2026INTEGRATED MEDCRAFT LLC
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Open, Classified
OHONone listed
Oct 9, 2026Becton Dickinson & Co.
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Open, Classified
LONK181665
Oct 9, 2026SI-BONE, Inc.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Open, Classified
OURK203247
Oct 9, 2026Ferno-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
FPONone listed
Oct 9, 2026Sarnova HC, Llc
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Open, Classified
CCXNone listed
Oct 9, 2026Boston Scientific Corporation
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Open, Classified
FGEK223592
Oct 9, 2026Neuronetics, 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
OBPK231926
K233621
Oct 9, 2026Cadwell 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
GWFK162199
Oct 9, 2026Becton Dickinson & Co.
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Open, Classified
LONK181665
Oct 9, 2026Medtronic 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
MBPK051188
K051195
Oct 9, 2026Medtronic 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
MBPK042707
K043048
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Open, Classified
NPTNone listed
Oct 7, 2026Steris 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
FTANone listed
Oct 7, 2026LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Open, Classified
DXEK022145
Oct 7, 2026Mindray DS USA, Inc.
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Open, Classified
MHXK190011
Oct 7, 2026Mindray DS USA, Inc.
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Open, Classified
MHXK153448
Oct 7, 2026Mindray DS USA, Inc.
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Open, Classified
MHXK153448
K190011
Oct 7, 2026Mindray DS USA, Inc.
BeneView Series. Operator's Manuals: T5 / T8
Open, Classified
MHXK092449
Oct 7, 2026Mindray DS USA, Inc.
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Open, Classified
MSXK242728
Oct 7, 2026Mindray DS USA, Inc.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Open, Classified
MSXK242728
Oct 7, 2026Mindray DS USA, Inc.
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Open, Classified
MHXK213799
Oct 7, 2026Mindray DS USA, Inc.
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Open, Classified
MHXK260098
Oct 7, 2026Intellijoint 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
OLOK191507
Oct 7, 2026AVID Medical, Inc.
ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
Open, Classified
OKVNone listed
Oct 7, 2026AVID Medical, Inc.
GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
Open, Classified
OKVNone listed
Oct 7, 2026AVID Medical, Inc.
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
Open, Classified
OKVNone listed