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)
Sep 16, 2026Stryker Sustainability Solutions
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Open, Classified
NLMK201511
Sep 16, 2026Stryker Sustainability Solutions
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Open, Classified
NLMK201511
Sep 16, 2026Stryker Sustainability Solutions
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Open, Classified
NLMK201511
Sep 16, 2026Stryker Sustainability Solutions
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Open, Classified
NLMK201511
Sep 16, 2026Medical Action Industries, Inc. 306
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
Open, Classified
OFMNone listed
Sep 16, 2026Howmedica Osteonics Corp.
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
NPJK051948
K052917 +2
Sep 16, 2026Howmedica Osteonics Corp.
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufacture
Open, Classified
N/ANone listed
Sep 16, 2026Howmedica Osteonics Corp.
TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
MEHK983502
Sep 16, 2026Howmedica Osteonics Corp.
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
MBHK033972
Sep 16, 2026Howmedica Osteonics Corp.
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufa
Open, Classified
LGENone listed
Sep 16, 2026Howmedica Osteonics Corp.
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50M
Open, Classified
KWZK261624
Sep 16, 2026Howmedica Osteonics Corp.
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #
Open, Classified
KWSK962082
Sep 16, 2026Howmedica Osteonics Corp.
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-
Open, Classified
KWLK261624
Sep 16, 2026Howmedica Osteonics Corp.
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
KROK223528
Sep 16, 2026Howmedica Osteonics Corp.
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SC
Open, Classified
JWHK243817
Sep 16, 2026Howmedica Osteonics Corp.
OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
JDLK850352
K900438
Sep 16, 2026embecta Medical II LLC
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Open, Classified
FMIK213478
Sep 16, 2026embecta Medical II LLC
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Open, Classified
FMIK212015
Sep 16, 2026Howmedica Osteonics Corp.
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified
JDCK980502
Sep 16, 2026restor3d Inc.
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Open, Classified
OYKK223326
Sep 16, 2026Wilson-Cook Medical Inc.
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic
Open, Classified
QAUK253302
Sep 15, 2026PTW FREIBURG
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Open, Classified
IYEK213370
Sep 15, 2026Straumann USA LLC
GM Helix Implant, REF: 109.984;
Open, Classified
DZEK163194
Sep 15, 2026WELL LEAD MEDICAL CO. LTD
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Open, Classified
BTRK042683
Sep 15, 2026GE Healthcare
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applic
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images an
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026GE Healthcare
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Open, Classified
LLZK043415
K110875
Sep 15, 2026NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System.
Open, Classified
MRNK171696
K201339 +3
Sep 15, 2026Happiest Baby, Inc
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534
Open, Classified
QTGNone listed
Sep 15, 2026Happiest Baby, Inc
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Open, Classified
QTGNone listed
Sep 15, 2026BD SWITZERLAND SARL
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Ala
Open, Classified
FPAK022209
Sep 14, 2026AVID Medical, Inc.
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Open, Classified
LRONone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A;
Open, Classified
OIBNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Open, Classified
MCYNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Open, Classified
LRSNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A;
Open, Classified
LRONone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Open, Classified
OFFNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
Open, Classified
OEZNone listed
Sep 14, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Open, Classified
CAINone listed
Sep 14, 2026Nuclein LLC
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH Rapid PCR Instrum
Open, Classified
NSUK241652
Sep 11, 2026Bayer Medical Care, Inc.
MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Open, Classified
DXTK182273
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Open, Classified
DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Open, Classified
DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Open, Classified
DWFK131666
Sep 11, 2026Nova Biomedical Corporation
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Open, Classified
PZINone listed
Sep 11, 2026Nova Biomedical Corporation
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Open, Classified
PZINone listed
Sep 11, 2026Nova Biomedical Corporation
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Open, Classified
PZINone listed