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.
- Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software P…
FDA Device · Class II · 2025-06-18 · Tecfen Medical - Z-800W Infusion System
FDA Device · Class I · 2025-06-18 · Zyno Medical - IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administra…
FDA Device · Class I · 2025-06-18 · Fresenius Kabi Usa - OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional to…
FDA Device · Class II · 2025-06-18 · Ge Medical Systems - Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
FDA Device · Class II · 2025-06-18 · Contamac Solutions - Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newpor…
FDA Device · Class I · 2025-06-18 · Covidien - Intera 1.5T Achieva Nova-Dual Product Number: 781173
FDA Device · Class II · 2025-06-18 · Philips North America - BD Texium Needle-Free Syringe: 3 mL, REF: MY8003
FDA Device · Class II · 2025-06-18 · Bd Switzerland Sarl - iBOT PMD with software version 01.05.24
FDA Device · Class II · 2025-06-18 · Mobius Mobility - Azure S DR MRI SureScan, Product number W3DR01
FDA Device · Class II · 2025-06-18 · Medtronic - Z-800WF Infusion System
FDA Device · Class I · 2025-06-18 · Zyno Medical - Baxter Novum IQ Syringe Pump, product code 40800BAXUS
FDA Device · Class II · 2025-06-18 · Baxter Healthcare - Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack
FDA Device · Class II · 2025-06-11 · Mozarc Medical Us - Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
FDA Device · Class I · 2025-06-11 · Medline Industries Northfield - MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
FDA Device · Class II · 2025-06-11 · Virtual Incision - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-06-11 · Foundation Medicine - Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Olympus EVIS EXERA III Duodenovideoscope
FDA Device · Class II · 2025-06-11 · Olympus - ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
FDA Device · Class II · 2025-06-11 · Healthmark Industries - FoundationOne Companion Diagnostic (F1CDx)
FDA Device · Class II · 2025-06-11 · Foundation Medicine - Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - MAHURKAR Chronic Hemodialysis Catheter Sport Pack
FDA Device · Class II · 2025-06-11 · Mozarc Medical Us - Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack
FDA Device · Class II · 2025-06-11 · Mozarc Medical Us - Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette
FDA Device · Class II · 2025-06-11 · Beckman Coulter Mishima K K - BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound tra…
FDA Device · Class II · 2025-06-11 · Civco Medical Instruments - Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIO…
FDA Device · Class I · 2025-06-11 · Medline Industries Northfield - Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - Access Testosterone assay, Catalog Number 33560
FDA Device · Class II · 2025-06-11 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
FDA Device · Class II · 2025-06-11 · Beckman Coulter - Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY…
FDA Device · Class I · 2025-06-11 · Medline Industries Northfield - Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette
FDA Device · Class II · 2025-06-11 · Beckman Coulter Mishima K K - Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack
FDA Device · Class II · 2025-06-11 · Mozarc Medical Us - Palindrome Precision Chronic Hemodialysis Catheter Sport Pack
FDA Device · Class II · 2025-06-11 · Mozarc Medical Us - Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
FDA Device · Class I · 2025-06-11 · Sunmed Holdings - Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
FDA Device · Class II · 2025-06-11 · Dexcom - Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
FDA Device · Class II · 2025-06-11 · Silex Medical - VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021
FDA Device · Class II · 2025-06-11 · Luminex - Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
FDA Device · Class II · 2025-06-11 · Healthmark Industries - Lazervida 10W diode laser cutter and engraver with Lazervida shield
FDA Device · Class II · 2025-06-11 · Flux Technology - Catalog No. 8888160333
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - DORO¿ Easy-Connect Navigation Adaptor
FDA Device · Class II · 2025-06-04 · Pro Med Instruments - BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP0…
FDA Device · Class II · 2025-06-04 · C Rad Positioning Ab - ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC…
FDA Device · Class II · 2025-06-04 · Onkos Surgical - Apo B Reagent, REF: OSR6143
FDA Device · Class III · 2025-06-04 · Beckman Coulter Ireland - a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH
FDA Device · Class II · 2025-06-04 · Onkos Surgical - ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT"…
FDA Device · Class II · 2025-06-04 · Prismatik Dentalcraft - ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - NxStage PureFlow-B Solution
FDA Device · Class II · 2025-06-04 · Nxstage Medical - ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip
FDA Device · Class II · 2025-06-04 · Onkos Surgical - Catalog No. 8888160341
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - GM Helix Acqua Implant, Article Number: 140.984
FDA Device · Class II · 2025-06-04 · Straumann Usa - ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Catalog No. 8888160119
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - VITROS Chemistry Products CRP Slides
FDA Device · Class II · 2025-06-04 · Ortho Clinical Diagnostics - Catalog No. 8888160648
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
FDA Device · Class II · 2025-06-04 · Onkos Surgical - Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH
FDA Device · Class II · 2025-06-04 · Onkos Surgical - ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3…
FDA Device · Class II · 2025-06-04 · Baxter Healthcare - BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA Device · Class II · 2025-06-04 · Biofire Diagnostics - ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Cardiohelp System HKH 8820 Wall Holder
FDA Device · Class II · 2025-06-04 · Maquet Cardiopulmonary Ag - Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
FDA Device · Class II · 2025-06-04 · Ultra Clean Systems - ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - GM Helix Acqua Implant, Article Number: 140.985
FDA Device · Class II · 2025-06-04 · Straumann Usa - Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M…
FDA Device · Class II · 2025-06-04 · Onkos Surgical - Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB…
FDA Device · Class II · 2025-06-04 · Onkos Surgical - ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip
FDA Device · Class II · 2025-06-04 · Onkos Surgical - Plus Initial Drill, Article Number: 103.170
FDA Device · Class II · 2025-06-04 · Straumann Usa - ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ADVIA Centaur HCY Calibrator (2 Pack)
FDA Device · Class II · 2025-06-04 · Siemens Healthcare Diagnostics - HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Atellica IM Homocysteine Calibrator (2 Pack)
FDA Device · Class II · 2025-06-04 · Siemens Healthcare Diagnostics - ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Catalog No. 8888160556
FDA Device · Class II · 2025-06-04 · Cardinal Health 200 - HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS L…
FDA Device · Class II · 2025-06-04 · Onkos Surgical
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