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: 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 - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/…
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
FDA Device · Class II · 2026-05-06 · Medline Industries - BD GasPak EZ Campy Pouch System
FDA Device · Class II · 2026-05-06 · Becton Dickinson And - BD GasPak EZ CO2 Pouch System
FDA Device · Class II · 2026-05-06 · Becton Dickinson And - Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296
FDA Device · Class II · 2026-05-06 · Philips North America - Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A
FDA Device · Class II · 2026-05-06 · Medline Industries - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Straumann n!ce Zr, HT, Full-arch Restoration
FDA Device · Class II · 2026-05-06 · Straumann Usa - Medtronic Sphere-9 Catheter, Model Number AFR-00001
FDA Device · Class II · 2026-05-06 · Medtronic - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SK…
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145
FDA Device · Class II · 2026-05-06 · Philips North America - Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262
FDA Device · Class II · 2026-05-06 · Philips North America - Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF):…
FDA Device · Class II · 2026-05-06 · Philips North America - Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF):…
FDA Device · Class II · 2026-05-06 · Philips North America - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162
FDA Device · Class II · 2026-05-06 · Philips North America - Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium sp…
FDA Device · Class II · 2026-05-06 · Immuno Mycologics - Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medlin…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 78210…
FDA Device · Class II · 2026-05-06 · Philips North America - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC3…
FDA Device · Class II · 2026-05-06 · Medline Industries - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110
FDA Device · Class II · 2026-05-06 · Advanced Bionics - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS9834…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
FDA Device · Class II · 2026-05-06 · Medline Industries - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medli…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ9…
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems
Other years
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