FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- Happiest Baby, Inc
FDA Device · Class II · 2026-09-23 · Happiest Baby - Philips PIC iX Essentials REF:867093
FDA Device · Class II · 2026-09-23 · Philips North America - Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - GM Helix Implant, REF: 109.984
FDA Device · Class II · 2026-09-23 · Straumann Usa - Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
FDA Device · Class II · 2026-09-23 · Embecta Medical Ii - DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150
FDA Device · Class I · 2026-09-23 · Bard Access Systems - Oncology sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Haylard 18G SINGLE SHOT EPI TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical - Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414
FDA Device · Class I · 2026-09-23 · Medline Industries - Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451
FDA Device · Class II · 2026-09-23 · Medical Action Industries 306 - 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…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured fro…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - 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,…
FDA Device · Class II · 2026-09-23 · Nuclein - CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-76…
FDA Device · Class II · 2026-09-23 · Icu Medical - 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 manufa…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - 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 GL…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B
FDA Device · Class I · 2026-09-23 · Medline Industries - StatStrip Glucose Hospital Meter System
FDA Device · Class I · 2026-09-23 · Nova Biomedical - SunMed Tracheal Tube, Size 2.5
FDA Device · Class II · 2026-09-23 · Well Lead Medical - Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Pro…
FDA Device · Class I · 2026-09-23 · Abiomed - Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
FDA Device · Class II · 2026-09-23 · Medline Industries - Philips Patient Information Center iX REF:866389
FDA Device · Class II · 2026-09-23 · Philips North America - Halyard IV START KIT NON-STERILE REF: KRIV26-02
FDA Device · Class I · 2026-09-23 · Avid Medical - Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A
FDA Device · Class I · 2026-09-23 · Medline Industries - Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-09-23 · Abiomed - Oncology sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - StatStrip Glucose and B- Ketone meter
FDA Device · Class I · 2026-09-23 · Nova Biomedical - Brand Name: VERIQA
FDA Device · Class II · 2026-09-23 · Ptw Freiburg - IV Non-Dedicated Gravity Administration Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-442…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - StatStrip Glucose and B- Ketone meter
FDA Device · Class I · 2026-09-23 · Nova Biomedical - Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM…
FDA Device · Class II · 2026-09-23 · Wilson Cook Medical - 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…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU
FDA Device · Class I · 2026-09-23 · Abiomed - Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150
FDA Device · Class I · 2026-09-23 · Bard Access Systems - REF:2B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - Pi-Cardia Inc
FDA Device · Class II · 2026-09-23 · Pi Cardia - StatStrip Glucose Hospital Meter System
FDA Device · Class I · 2026-09-23 · Nova Biomedical - Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,…
FDA Device · Class II · 2026-09-23 · Boston Scientific - REF:B11LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - REF:B5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - Haylard BASIC BIOPSY TRAY
FDA Device · Class I · 2026-09-23 · Avid Medical - Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
FDA Device · Class II · 2026-09-23 · Medline Industries - Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y
FDA Device · Class I · 2026-09-23 · Medline Industries - MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
FDA Device · Class II · 2026-09-23 · Bayer Medical Care - EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
FDA Device · Class II · 2026-09-23 · Embecta Medical Ii - REF:B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (poly…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field repla…
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - Plum administration sets
FDA Device · Class II · 2026-09-23 · Icu Medical - Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
FDA Device · Class II · 2026-09-23 · Happiest Baby - Haylard UNIV IMAGING BIOPSY TRUCUSTOM
FDA Device · Class I · 2026-09-23 · Avid Medical - ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154
FDA Device · Class II · 2026-09-23 · Mirion Technologies Capintec - REF:2B5ST Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - StatStrip Glucose and B- Ketone meter
FDA Device · Class I · 2026-09-23 · Nova Biomedical - Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number…
FDA Device · Class II · 2026-09-23 · Ge Medical Systems Information Technologies - Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - 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 IN…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - IV Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - REF:B12LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2026-09-23 · Stryker Sustainability Solutions - Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
FDA Device · Class I · 2026-09-23 · Medline Industries - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - IV Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - Convenience kits CATARACT PACK DYNJ59881A
FDA Device · Class II · 2026-09-23 · Medline Industries - BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 Sma…
FDA Device · Class I · 2026-09-23 · Bd Switzerland Sarl - NOxBOXi Nitric Oxide Delivery System
FDA Device · Class II · 2026-09-23 · Noxbox - Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
FDA Device · Class II · 2026-09-23 · Restor3d - Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
FDA Device · Class II · 2026-09-23 · Datex Ohmeda - IV Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - Kit: Single Shot Epidural 20/Cs, REF: 59553
FDA Device · Class I · 2026-09-16 · Medical Action Industries 306 - AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
FDA Device · Class II · 2026-09-16 · Windstone Medical Packaging - Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741…
FDA Device · Class II · 2026-09-16 · C R Bard - Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532…
FDA Device · Class II · 2026-09-16 · Lutronic - Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 108017411…
FDA Device · Class II · 2026-09-16 · C R Bard - Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636
FDA Device · Class I · 2026-09-16 · Given Imaging - Halyard IV Start Kit Non-Sterile REF: KRIV26-02
FDA Device · Class II · 2026-09-16 · Avid Medical - MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes:…
FDA Device · Class II · 2026-09-16 · C R Bard - MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 0…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08…
FDA Device · Class II · 2026-09-16 · C R Bard - HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Mi…
FDA Device · Class II · 2026-09-16 · Heartsine Technologies - Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 1080174…
FDA Device · Class II · 2026-09-16 · C R Bard - Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
FDA Device · Class I · 2026-09-16 · Medical Action Industries 306
Other years
2026 (2,388) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)