FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,024 FDA Device recall notices published in 2026. By classification: 254 Class I, 1,736 Class II, 34 Class III.
- Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
FDA Device · Class II · 2026-09-02 · Medline Industries - Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product…
FDA Device · Class II · 2026-09-02 · Medline Industries - American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
FDA Device · Class II · 2026-09-02 · American Contract Systems - Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144
FDA Device · Class II · 2026-09-02 · Philips Healthcare Suzhou - ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
FDA Device · Class II · 2026-09-02 · Imris Imaging - Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A
FDA Device · Class II · 2026-09-02 · Medline Industries - CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 me…
FDA Device · Class II · 2026-09-02 · Conmed - Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 a…
FDA Device · Class II · 2026-09-02 · Midmark - Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U
FDA Device · Class II · 2026-09-02 · Medline Industries - Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent…
FDA Device · Class II · 2026-09-02 · Canon Medical System Usa - FUJIFILM Synapse PACS software v7.4.310
FDA Device · Class II · 2026-09-02 · Fujifilm Healthcare Americas - Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q
FDA Device · Class II · 2026-09-02 · Medline Industries - Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF…
FDA Device · Class II · 2026-09-02 · Hollister Ulc - Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (…
FDA Device · Class II · 2026-09-02 · Medline Industries - healthmark ProChek-W Protein Test for Robotic Arms
FDA Device · Class II · 2026-09-02 · Healthmark Industries - Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840
FDA Device · Class II · 2026-09-02 · Henry Schein - Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L
FDA Device · Class II · 2026-09-02 · Medline Industries - Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F
FDA Device · Class II · 2026-09-02 · Medline Industries - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19)
FDA Device · Class II · 2026-09-02 · Medline Industries - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
FDA Device · Class II · 2026-09-02 · Medline Industries - ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Cov…
FDA Device · Class II · 2026-09-02 · Imris Imaging - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479
FDA Device · Class II · 2026-09-02 · Henry Schein - Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U
FDA Device · Class II · 2026-09-02 · Medline Industries - healthmark ProChek-II, Model Number PT-313, PT-201-12
FDA Device · Class II · 2026-09-02 · Healthmark Industries - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
FDA Device · Class II · 2026-09-02 · Avid Medical - PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
FDA Device · Class II · 2026-09-02 · American Contract Systems - Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and pr…
FDA Device · Class II · 2026-09-02 · Midmark - FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y
FDA Device · Class II · 2026-09-02 · Medline Industries - Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130
FDA Device · Class II · 2026-09-02 · Fresenius Medical Care Renal Therapies Group - Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548
FDA Device · Class II · 2026-09-02 · Medline Industries - Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P
FDA Device · Class II · 2026-09-02 · Medline Industries - PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
FDA Device · Class II · 2026-09-02 · Ge Medical Systems Information Technologies - Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J
FDA Device · Class II · 2026-09-02 · Medline Industries - Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F
FDA Device · Class II · 2026-09-02 · Medline Industries - POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action
FDA Device · Class II · 2026-09-02 · Olympus - Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
FDA Device · Class II · 2026-09-02 · Medline Industries - Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C
FDA Device · Class II · 2026-09-02 · Medline Industries - American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
FDA Device · Class II · 2026-09-02 · American Contract Systems - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
FDA Device · Class II · 2026-09-02 · Avid Medical - Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545
FDA Device · Class II · 2026-09-02 · Medline Industries - American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
FDA Device · Class II · 2026-09-02 · American Contract Systems - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics Products - Ami HTX
FDA Device · Class II · 2026-08-26 · Spectral Instruments - Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
FDA Device · Class II · 2026-08-26 · Tobii Dynavox - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Dentsply Sirona Capsule Mixer Model No. 5546068
FDA Device · Class II · 2026-08-26 · Sdi - MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - OverStitch Suture Cinch, 1pk
FDA Device · Class II · 2026-08-26 · Boston Scientific - Paragonix Technologies Inc
FDA Device · Class II · 2026-08-26 · Paragonix Technologies - EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 1088452180809…
FDA Device · Class II · 2026-08-26 · Covidien - American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH
FDA Device · Class II · 2026-08-26 · American Contract Systems - Blanketrol II Model 222S
FDA Device · Class II · 2026-08-26 · Gentherm Medical - Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R
FDA Device · Class III · 2026-08-26 · Paragon 28 - TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
FDA Device · Class II · 2026-08-26 · Tobii Dynavox - BMC/REACTHEALTH Luna G3 APAP REF LG 3600
FDA Device · Class I · 2026-08-26 · Bmc Medical - American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI
FDA Device · Class II · 2026-08-26 · American Contract Systems - Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-35…
FDA Device · Class II · 2026-08-26 · Arrowhead De - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter - Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R
FDA Device · Class III · 2026-08-26 · Paragon 28 - MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - Cardiac Workstation 7000
FDA Device · Class II · 2026-08-26 · Philips North America - Blanketrol III, Model 233
FDA Device · Class II · 2026-08-26 · Gentherm Medical - Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030
FDA Device · Class II · 2026-08-26 · Restor3d - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519
FDA Device · Class II · 2026-08-26 · Beckman Coulter - Cardiac Workstation 5000
FDA Device · Class II · 2026-08-26 · Philips North America - Lago X
FDA Device · Class II · 2026-08-26 · Spectral Instruments - Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVI…
FDA Device · Class II · 2026-08-26 · Kico Knee Innovation - Suture Cinch Long 1pk
FDA Device · Class II · 2026-08-26 · Boston Scientific - Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS
FDA Device · Class I · 2026-08-26 · Boston Scientific - Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 42371…
FDA Device · Class II · 2026-08-26 · Convatec - Hamilton Microlab STAR Liquid Handler
FDA Device · Class II · 2026-08-26 · Foundation Medicine - BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit f…
FDA Device · Class I · 2026-08-26 · Bard Access Systems - One-Piece Guedel Airway, size 000, ISO 3.5, Light Green
FDA Device · Class II · 2026-08-26 · Intersurgical - Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907)
FDA Device · Class II · 2026-08-26 · Avid Medical - Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
FDA Device · Class II · 2026-08-26 · Fort Defiance Industries - MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662
FDA Device · Class II · 2026-08-26 · Maquet Critical Care Ab - Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS
FDA Device · Class I · 2026-08-26 · Boston Scientific - One-Piece Guedel Airway, size 00, ISO 5.0, Blue
FDA Device · Class II · 2026-08-26 · Intersurgical - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics Products - Innercool Coolblue Console, Model STx
FDA Device · Class II · 2026-08-26 · Gentherm Medical - navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI…
FDA Device · Class II · 2026-08-19 · Ventana Medical Systems - Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and…
FDA Device · Class II · 2026-08-19 · Microvention - Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901
FDA Device · Class II · 2026-08-19 · Remel Europe - Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0…
FDA Device · Class II · 2026-08-19 · Covidien - Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
FDA Device · Class II · 2026-08-19 · Medline Industries - Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelab…
FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare - V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2…
FDA Device · Class II · 2026-08-19 · Covidien
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)