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.
- ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"
FDA Device · Class II · 2025-11-05 · Icu Medical - Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
FDA Device · Class II · 2025-11-05 · Carefusion 303 - Refill 3 Month All in One Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical ChemoLock Closed Vial Spike REF: CL-80
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
FDA Device · Class II · 2025-11-05 · Icu Medical - Refill 3 Month Regular Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Refill 18 Coated Regular and 18 Nude Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
FDA Device · Class II · 2025-11-05 · Surgical Theater - Magseed Pro 12 cm soft tissue marker
FDA Device · Class II · 2025-11-05 · Endomagnetics - Model: CT 5300
FDA Device · Class II · 2025-11-05 · Philips Medical Systems - ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
FDA Device · Class II · 2025-11-05 · Icu Medical - Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-0…
FDA Device · Class II · 2025-11-05 · Carefusion 303 - Trial Tampon Box
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
FDA Device · Class II · 2025-11-05 · Icu Medical - BD Pyxis Pro MedStation Main, REF: 1155-00
FDA Device · Class II · 2025-11-05 · Carefusion 303 - IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
FDA Device · Class I · 2025-11-05 · Impris Imaging - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research - 9 Coated Super and 9 Nude Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - 18 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
FDA Device · Class II · 2025-11-05 · Icu Medical - Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
FDA Device · Class II · 2025-11-05 · Greiner Bio One North America - ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
FDA Device · Class II · 2025-11-05 · Icu Medical - Magseed Pro 7 cm soft tissue marker
FDA Device · Class II · 2025-11-05 · Endomagnetics - ICU Medical ChemosafeLock Connecter REF: KL-FNU3
FDA Device · Class II · 2025-11-05 · Icu Medical - IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Device · Class I · 2025-11-05 · Impris Imaging - 9 Coated Regular and 9 Nude Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Model: Incisive CT for Brazil SKD
FDA Device · Class II · 2025-11-05 · Philips Medical Systems - Refill 36 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - 18 Coated Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
FDA Device · Class II · 2025-11-05 · Icu Medical - IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
FDA Device · Class I · 2025-11-05 · Impris Imaging - ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
FDA Device · Class II · 2025-11-05 · Icu Medical - Alcon PRECISION1 One-Day Contact Lenses, -2.25D
FDA Device · Class II · 2025-11-05 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research - All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
FDA Device · Class II · 2025-11-05 · Carefusion 303 - Model: Incisive CT
FDA Device · Class II · 2025-11-05 · Philips Medical Systems - ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port
FDA Device · Class II · 2025-11-05 · Icu Medical - Refill 36 Coated Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
FDA Device · Class II · 2025-11-05 · Icu Medical - Initiation 3 Month Regular Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
FDA Device · Class II · 2025-11-05 · Icu Medical - 9 Coated Regular Tampons and 9 Nude Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
FDA Device · Class II · 2025-11-05 · Icu Medical - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap - ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
FDA Device · Class II · 2025-11-05 · Icu Medical - SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
FDA Device · Class II · 2025-11-05 · Surgical Theater - 9 Coated Regular and 9 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Initiation 36 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Initiation 18 Coated Regular and 18 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Refill 18 Coated Super and 18 Nude Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Kor…
FDA Device · Class II · 2025-11-05 · Vantive Us Healthcare - ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
FDA Device · Class II · 2025-11-05 · Icu Medical - Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological syst…
FDA Device · Class II · 2025-11-05 · Surgical Theater - Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 1389…
FDA Device · Class II · 2025-11-05 · Carefusion 303 - Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software…
FDA Device · Class II · 2025-11-05 · Medistim Asa - Initiation 18 Coated Regular and 18 Nude Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotatin…
FDA Device · Class II · 2025-11-05 · Icu Medical - Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, ME…
FDA Device · Class I · 2025-11-05 · Balt Usa - ICU Medical ChemoLock Port REF: CL2100
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
FDA Device · Class II · 2025-11-05 · Icu Medical - Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Cod…
FDA Device · Class I · 2025-10-29 · Abiomed - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number 40KW-FX.899, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing…
FDA Device · Class II · 2025-10-29 · Synthes Usa Products - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Elscint Helix
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, P…
FDA Device · Class II · 2025-10-29 · Ge Medical Systems - Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm)…
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - Model SM-32HF-Batt
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - Model Number 40KWFXPLUS.004, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120…
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - Model Number 40KWFX, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-Batt
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - SM_40HF_BDC, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Maxicam
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - Elscint SPX4
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Model Number SM-32HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-20HF-Batt
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834
FDA Device · Class II · 2025-10-29 · Biomet - DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521…
FDA Device · Class II · 2025-10-29 · Beckman Coulter
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)