FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- 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 - Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
FDA Device · Class II · 2026-08-19 · Waldemar Link And Kg Mfg Site - Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - GM Helix Implant, Endosseous Dental Implant Article No. 109.984
FDA Device · Class II · 2026-08-19 · Straumann Usa - Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507
FDA Device · Class I · 2026-08-19 · Baxter Healthcare - Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)
FDA Device · Class II · 2026-08-19 · Straumann Usa - BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics - Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI c…
FDA Device · Class II · 2026-08-19 · Bd Switzerland Sarl - Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol…
FDA Device · Class II · 2026-08-19 · Galt Medical - ProNephro AKI (NGAL) Reagent Kit (100 tests)
FDA Device · Class II · 2026-08-19 · Bioporto Diagnostics A S - Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
FDA Device · Class II · 2026-08-19 · Covidien - Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
FDA Device · Class II · 2026-08-19 · Medline Industries - Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10ML…
FDA Device · Class I · 2026-08-19 · Spectra Medical Devices - Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
FDA Device · Class II · 2026-08-19 · Covidien - Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
FDA Device · Class II · 2026-08-19 · Cardinal Health 200 - Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
FDA Device · Class II · 2026-08-19 · Medline Industries - ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
FDA Device · Class II · 2026-08-19 · Erbe Usa - GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical - OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
FDA Device · Class II · 2026-08-19 · Obp Medical - GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006
FDA Device · Class II · 2026-08-19 · W L Gore And Associates - Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
FDA Device · Class II · 2026-08-19 · Covidien - Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
FDA Device · Class II · 2026-08-19 · Medline Industries - Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
FDA Device · Class II · 2026-08-12 · Medical Action Industries 306 - STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
FDA Device · Class II · 2026-08-12 · Stryker - Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Softwar…
FDA Device · Class II · 2026-08-12 · United Orthopedic - GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
FDA Device · Class II · 2026-08-12 · Ge Medical Systems Information Technologies - Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13…
FDA Device · Class II · 2026-08-12 · Pride Mobility Products - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
FDA Device · Class II · 2026-08-12 · Hardy Diagnostics
Other years
2026 (2,388) · 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)