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 medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C
FDA Device · Class I · 2026-05-20 · Medline Industries - Daig Livewire Steerable, Product Number 401932
FDA Device · Class II · 2026-05-20 · Stryker Sustainability Solutions - Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard VA DETROIT CATH LAB PACK kit
FDA Device · Class I · 2026-05-13 · Avid Medical - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185
FDA Device · Class II · 2026-05-13 · Medline Industries - VOCSN V+Pro package, REF: PRT-01198-000
FDA Device · Class I · 2026-05-13 · Ventec Life Systems - Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B
FDA Device · Class II · 2026-05-13 · Medline Industries - Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with go…
FDA Device · Class I · 2026-05-13 · Cook - Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW…
FDA Device · Class II · 2026-05-13 · Boston Scientific - QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Device · Class II · 2026-05-13 · Dfi - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard CATH LAB kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-05-13 · Intuitive Surgical - Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement
FDA Device · Class II · 2026-05-13 · Centinel Spine - One Step pH in vitro diagnostic test REF: 31I4P
FDA Device · Class II · 2026-05-13 · Dfi - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a vari…
FDA Device · Class I · 2026-05-13 · Cook - Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard CARDIAC CATH PACK kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard NEURO IR PERIPHERAL (PS 64405) kit
FDA Device · Class I · 2026-05-13 · Avid Medical - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Uric Acid in vitro diagnostic test REF: 31H0P
FDA Device · Class II · 2026-05-13 · Dfi - Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement
FDA Device · Class II · 2026-05-13 · Centinel Spine - Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
FDA Device · Class II · 2026-05-13 · Medline Industries - ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201
FDA Device · Class II · 2026-05-13 · Erbe Medical - Halyard CARDIAC CATH TRAY SHANDS JAX kit
FDA Device · Class I · 2026-05-13 · Avid Medical - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Halyard SAMMC ANGIOGRAPHY kit
FDA Device · Class I · 2026-05-13 · Avid Medical - One Step 10A in vitro diagnostic test
FDA Device · Class II · 2026-05-13 · Dfi - See complete list in RES, exceeds character limit
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G
FDA Device · Class II · 2026-05-13 · Medline Industries - Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-C…
FDA Device · Class I · 2026-05-13 · Cook - One Step P in vitro diagnostic test REF: 8194
FDA Device · Class II · 2026-05-13 · Dfi - Halyard CARDIAC CATH PACK SAN23CARDQ kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
FDA Device · Class II · 2026-05-13 · Medline Industries - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB
FDA Device · Class II · 2026-05-13 · Medline Industries - One Step K in vitro diagnostic test REF: 81A4
FDA Device · Class II · 2026-05-13 · Dfi - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
FDA Device · Class II · 2026-05-13 · Medline Industries - ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239
FDA Device · Class II · 2026-05-13 · Erbe Medical - LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
FDA Device · Class II · 2026-05-13 · Boston Scientific - Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Medical Action Industries Inc
FDA Device · Class I · 2026-05-13 · Medical Action Industries 306 - Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA Device · Class I · 2026-05-13 · Intuitive Surgical - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - One Step UTI in vitro diagnostic test REF: 3374
FDA Device · Class II · 2026-05-13 · Dfi - Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - See RES for full list
FDA Device · Class II · 2026-05-13 · Medline Industries - Halyard HEART CATH, SELF REGIONAL kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Halyard CATH LAB kit
FDA Device · Class I · 2026-05-13 · Avid Medical - Mint Lesion
FDA Device · Class II · 2026-05-13 · Mint Medical - Halyard PERC TRAY kit
FDA Device · Class I · 2026-05-13 · Avid Medical - See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N
FDA Device · Class II · 2026-05-13 · Medline Industries - Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP AN…
FDA Device · Class I · 2026-05-13 · American Contract Systems - Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare - ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Device · Class II · 2026-05-13 · Erbe Medical - BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
FDA Device · Class II · 2026-05-13 · Orthorebirth - ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
FDA Device · Class II · 2026-05-13 · Orthorebirth - Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK
FDA Device · Class II · 2026-05-13 · Medline Industries - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
FDA Device · Class II · 2026-05-13 · Katalyst Surgical - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG
FDA Device · Class II · 2026-05-13 · Medline Industries - LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-0019…
FDA Device · Class II · 2026-05-13 · Physio Control - Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N
FDA Device · Class II · 2026-05-13 · Medline Industries - See RES for complete list
FDA Device · Class II · 2026-05-13 · Medline Industries - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035
FDA Device · Class II · 2026-05-13 · Medline Industries - Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178
FDA Device · Class II · 2026-05-06 · Philips North America - Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU U…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion),…
FDA Device · Class II · 2026-05-06 · Medline Industries - VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
FDA Device · Class II · 2026-05-06 · Milestone S R L
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)