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) |
|---|---|---|---|
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B12LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B11LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:2B5ST
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:2B5LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Medical 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 |
OFM | None listed |
| Sep 16, 2026 | Howmedica 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 |
NPJ | K051948 K052917 +2 |
| Sep 16, 2026 | Howmedica 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/A | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIDENT 0 POLY INSERT 28mm ID
620-00-28D
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MEH | K983502 |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO RECESSED METAL BACKED PATELLA
3045-0026
3045-0028
3045-0030
3045-0032
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MBH | K033972 |
| Sep 16, 2026 | Howmedica 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 |
LGE | None listed |
| Sep 16, 2026 | Howmedica 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 |
KWZ | K261624 |
| Sep 16, 2026 | Howmedica 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 |
KWS | K962082 |
| Sep 16, 2026 | Howmedica 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 |
KWL | K261624 |
| Sep 16, 2026 | Howmedica 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 |
KRO | K223528 |
| Sep 16, 2026 | Howmedica 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 |
JWH | K243817 |
| Sep 16, 2026 | Howmedica Osteonics Corp. OMNIFIT SERIES I ACET. INSERT 10 22mm ID
Catalog No. 2001-2246
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDL | K850352 K900438 |
| Sep 16, 2026 | embecta Medical II LLC EWO_02513 (Catalog number 320122)
For Investigational Use Only
Nano Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K213478 |
| Sep 16, 2026 | embecta Medical II LLC EWO_02512 (Catalog number 320550)
For Investigational Use Only
Nano Pro Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | K212015 |
| Sep 16, 2026 | Howmedica Osteonics Corp. AXLE PIN ASSY LARGE ELBOW COBALT CHROME
Catalog No. C-M112-2-500
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDC | K980502 |
| Sep 16, 2026 | restor3d Inc. Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 Open, Classified |
OYK | K223326 |
| Sep 16, 2026 | Wilson-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 |
QAU | K253302 |
| Sep 15, 2026 | PTW FREIBURG Brand Name: VERIQA;
Product Name: RT MonteCarlo 3D v3;
Model/Catalog Number: S070031.520;
Software Version: 3.1.18; Open, Classified |
IYE | K213370 |
| Sep 15, 2026 | Straumann USA LLC GM Helix Implant, REF: 109.984; Open, Classified |
DZE | K163194 |
| Sep 15, 2026 | WELL LEAD MEDICAL CO. LTD SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 Open, Classified |
BTR | K042683 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE 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 |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | NOXBOX LTD NOxBOXi Nitric Oxide Delivery System. Open, Classified |
MRN | K171696 K201339 +3 |
| Sep 15, 2026 | Happiest 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 |
QTG | None listed |
| Sep 15, 2026 | Happiest 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 |
QTG | None listed |
| Sep 15, 2026 | BD 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 |
FPA | K022209 |
| Sep 14, 2026 | AVID Medical, Inc. Halyard IV START KIT NON-STERILE
REF: KRIV26-02 Open, Classified |
LRO | None listed |
| Sep 14, 2026 | Medline 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 |
OIB | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDH1193, Catalog Number: DYNDH1193;
2) DYNDH1487A, Catalog Number: DYNDH1487A Open, Classified |
MCY | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYKM1000B, Catalog Number: DYKM1000B;
2) DYKM2187A, Catalog Number: DYKM2187A Open, Classified |
LRS | None listed |
| Sep 14, 2026 | Medline 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 |
LRO | None listed |
| Sep 14, 2026 | Medline 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 |
OFF | None listed |
| Sep 14, 2026 | Medline 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 |
OEZ | None listed |
| Sep 14, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A Open, Classified |
CAI | None listed |
| Sep 14, 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, 6.0.4, 6.0.5, 6.0.6
Product Description: The DASH Rapid PCR Instrum Open, Classified |
NSU | K241652 |
| Sep 11, 2026 | Bayer Medical Care, Inc. MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System;
Catalog number: FLEXS-150-QFT; Open, Classified |
DXT | K182273 |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS); Open, Classified |
DWF | K131666 |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS); Open, Classified |
DWF | K131666 |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS); Open, Classified |
DWF | K131666 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. Open, Classified |
PZI | None listed |