FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
FDA Device · Class I · 2023-03-01 · Draeger Medical - Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
FDA Device · Class II · 2023-03-01 · Cardinal Health 200 - Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
FDA Device · Class II · 2023-03-01 · Cardinal Health 200 - ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red bloo…
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
FDA Device · Class II · 2023-03-01 · Cardinal Health 200 - abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Fa…
FDA Device · Class III · 2023-03-01 · S And Mohr America - Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood…
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
FDA Device · Class II · 2023-03-01 · Siemens Medical Solutions Usa - Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies
FDA Device · Class II · 2023-03-01 · Siemens Medical Solutions Usa - Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
FDA Device · Class II · 2023-03-01 · Siemens Medical Solutions Usa - Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
FDA Device · Class II · 2023-03-01 · Siemens Medical Solutions Usa - NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
FDA Device · Class I · 2023-03-01 · Draeger Medical - (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815…
FDA Device · Class II · 2023-03-01 · Medline Industries Northfield - ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cel…
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-0500…
FDA Device · Class II · 2023-03-01 · Hologic - (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator,…
FDA Device · Class II · 2023-03-01 · Medline Industries Northfield - ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies t…
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG,…
FDA Device · Class II · 2023-03-01 · Medline Industries Northfield - EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid…
FDA Device · Class II · 2023-02-22 · Olympus - Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - SIEMENS Biograph Horizon 3R Mobile
FDA Device · Class II · 2023-02-22 · Siemens Medical Solutions Usa - Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Orthex Large Bone Shoulder Bolt, model no
FDA Device · Class II · 2023-02-22 · Orthopediatrics - Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BU…
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
FDA Device · Class II · 2023-02-22 · Conformis - EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
FDA Device · Class II · 2023-02-22 · Microport Orthopedics - SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
FDA Device · Class II · 2023-02-22 · Siemens Medical Solutions Usa - Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3…
FDA Device · Class II · 2023-02-22 · Siemens Medical Solutions Usa - EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
FDA Device · Class II · 2023-02-22 · Microport Orthopedics - Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
FDA Device · Class II · 2023-02-22 · Access Vascular - Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
FDA Device · Class II · 2023-02-22 · Access Vascular - HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
FDA Device · Class II · 2023-02-22 · Access Vascular - Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
FDA Device · Class II · 2023-02-22 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch…
FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging - Identity Shoulder System Resection Planer 35mm Resection Planer
FDA Device · Class II · 2023-02-15 · Zimmer - GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50H…
FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging - Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOF…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH V…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile
FDA Device · Class II · 2023-02-15 · Trackx Technology - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
FDA Device · Class III · 2023-02-15 · Nuvasive - Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART C…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
FDA Device · Class II · 2023-02-15 · Olympus - Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PA…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - ANCILLARY PACK-LF. Sterile Procedural Tray
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: IM NAIL
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e.…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
FDA Device · Class III · 2023-02-15 · Owens And Minor Distribution - Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTH…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - HIGH V+ Spinal Cement System REF T040321K
FDA Device · Class II · 2023-02-15 · Teknimed Sas - Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e.…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Precision Delivery Set with Filter, REF: PD06F
FDA Device · Class II · 2023-02-15 · Quest Medical - Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework
FDA Device · Class II · 2023-02-15 · Bard Peripheral Vascular - FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: LS MS PACK
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - LOCAL PACK. Sterile Procedural Tray
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d.…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-L…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - RipCord Syndesmosis Button, REF: STA001K
FDA Device · Class II · 2023-02-15 · Trimed - Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHR…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3…
FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging - Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK C…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount,…
FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging - GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3…
FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging - Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJO…
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield - Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF
FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
Other years
2026 (2,024) · 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)