FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM…
FDA Device · Class II · 2025-04-02 · St Jude Medical - Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
FDA Device · Class I · 2025-04-02 · Covidien - Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G
FDA Device · Class II · 2025-04-02 · Medline Industries Northfield - Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes…
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - Baxter Mobile column TruSystem 7500, Product Code 1717023
FDA Device · Class II · 2025-04-02 · Baxter Healthcare - CYSTO PACK , Model N. HKCY31A
FDA Device · Class II · 2025-03-26 · American Contract Systems - LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
FDA Device · Class II · 2025-03-26 · American Contract Systems - LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
FDA Device · Class II · 2025-03-26 · American Contract Systems - EAR PACK , Model No SFEA12A
FDA Device · Class II · 2025-03-26 · American Contract Systems - Zebra Thermal Barcode Printer GX430t, Model no
FDA Device · Class II · 2025-03-26 · Remel - CAPNOCHECK BCI Airway Adapter
FDA Device · Class II · 2025-03-26 · Smiths Medical Asd - smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
FDA Device · Class II · 2025-03-26 · American Contract Systems - LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
FDA Device · Class II · 2025-03-26 · American Contract Systems - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare - LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
FDA Device · Class II · 2025-03-26 · American Contract Systems - Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
FDA Device · Class II · 2025-03-26 · Waldemar Link And Kg Mfg Site - CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit
FDA Device · Class II · 2025-03-26 · American Contract Systems - CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
FDA Device · Class II · 2025-03-26 · American Contract Systems - DELIVERY PACK , Model No SGDV22D-01 SGDV22E
FDA Device · Class II · 2025-03-26 · American Contract Systems - Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
FDA Device · Class II · 2025-03-26 · Waldemar Link And Kg Mfg Site - Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3
FDA Device · Class II · 2025-03-26 · Merge Healthcare - C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 0…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT001563…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1
FDA Device · Class II · 2025-03-26 · Merge Healthcare - Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. St…
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - Access 2 Immunoassay Analyzer, Catalog Number 81600N
FDA Device · Class II · 2025-03-26 · Beckman Coulter - MAJOR DIEP, Model Nos
FDA Device · Class II · 2025-03-26 · American Contract Systems - AV FISTULA , Model No UTAV77T
FDA Device · Class II · 2025-03-26 · American Contract Systems - THORACIC PACK , Model No UTTC82Y UTTC82AA-01
FDA Device · Class II · 2025-03-26 · American Contract Systems - LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
FDA Device · Class II · 2025-03-26 · American Contract Systems - DIAGNOSTIC NEURO IR TRAY , Model No WENE21
FDA Device · Class II · 2025-03-26 · American Contract Systems - VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Micros…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
FDA Device · Class II · 2025-03-26 · American Contract Systems - smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
FDA Device · Class II · 2025-03-26 · Beckman Coulter - IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
FDA Device · Class II · 2025-03-26 · Angiodynamics - NEURO IR TRAY , Model No WENI56J
FDA Device · Class II · 2025-03-26 · American Contract Systems - Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem
FDA Device · Class II · 2025-03-26 · Zimmer Orthopedics Manfacturing Galway - DR DIULUS INJECTION PACK, Model Nos
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pe…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
FDA Device · Class II · 2025-03-26 · Waldemar Link And Kg Mfg Site - Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
FDA Device · Class II · 2025-03-26 · American Contract Systems - smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
FDA Device · Class II · 2025-03-26 · American Contract Systems - BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES D…
FDA Device · Class II · 2025-03-26 · Carefusion 303 - Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - HIP SCOPE, Model Nos
FDA Device · Class II · 2025-03-26 · American Contract Systems - smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare - Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for u…
FDA Device · Class II · 2025-03-26 · Immuno Mycologics - URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - M…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
FDA Device · Class II · 2025-03-26 · American Contract Systems - CYSTO , Model No SACY80R
FDA Device · Class II · 2025-03-26 · American Contract Systems - smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - CV BASIC PUMP PACK , Model No WECV23D
FDA Device · Class II · 2025-03-26 · American Contract Systems - Synapse PACS Software Version 7.4.x
FDA Device · Class II · 2025-03-26 · Fujifilm Healthcare Americas - Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Device · Class II · 2025-03-26 · Brainlab Ag - smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., RE…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - CAPNOCHECK BCI Airway Adapter
FDA Device · Class II · 2025-03-26 · Smiths Medical Asd - Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT001…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - BORN ON ARRIVAL KIT , Model No LLBN11B
FDA Device · Class II · 2025-03-26 · American Contract Systems - Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged
FDA Device · Class II · 2025-03-26 · B Braun Medical - Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ0…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
FDA Device · Class II · 2025-03-26 · Beckman Coulter - Proxima Drape labeled as FACE LIFT. Sterile surgical drape
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog…
FDA Device · Class II · 2025-03-26 · Microbiologics - TOTAL HIP PACK , Model No SMTH06O SMTH06P
FDA Device · Class II · 2025-03-26 · American Contract Systems - smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introduce…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 2…
FDA Device · Class I · 2025-03-26 · Smiths Medical Asd - Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal,…
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8
FDA Device · Class II · 2025-03-26 · Merge Healthcare - OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
FDA Device · Class II · 2025-03-26 · American Contract Systems - Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv
FDA Device · Class II · 2025-03-26 · Oridion Medical 1987 - Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape
FDA Device · Class II · 2025-03-26 · Medline Industries Northfield - SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
FDA Device · Class II · 2025-03-26 · American Contract Systems - LABOR & DELIVERY PACK, Model Nos LLLD19H
FDA Device · Class II · 2025-03-26 · American Contract Systems - COR Disposable Kit, 8 mm w/ Perpendicularity
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C
FDA Device · Class II · 2025-03-19 · Zoll Medical - GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
FDA Device · Class II · 2025-03-19 · Ge Medical Systems - Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6)…
FDA Device · Class II · 2025-03-19 · Zoll Medical - Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/12…
FDA Device · Class I · 2025-03-19 · Smiths Medical Asd
Other years
2026 (2,088) · 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)