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 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 - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ…
FDA Device · Class II · 2026-05-06 · Medline Industries - AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the ap…
FDA Device · Class I · 2026-05-06 · North American Rescue - Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ05…
FDA Device · Class II · 2026-05-06 · Medline Industries - i-STAT G3+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ05…
FDA Device · Class II · 2026-05-06 · Medline Industries - Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Ve…
FDA Device · Class II · 2026-05-06 · Hologic - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS9…
FDA Device · Class II · 2026-05-06 · Medline Industries - Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Versio…
FDA Device · Class II · 2026-05-06 · Zimmer - Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model N…
FDA Device · Class II · 2026-05-06 · Philips North America - iLet Bionic Pancreas, REF: BB1001
FDA Device · Class II · 2026-05-06 · Beta Bionics - i-STAT EG6+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479
FDA Device · Class II · 2026-05-06 · Medline Industries - epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
FDA Device · Class II · 2026-05-06 · Siemens Healthcare Diagnostics - Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF):…
FDA Device · Class II · 2026-05-06 · Philips North America - Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153
FDA Device · Class II · 2026-05-06 · Philips North America - Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125
FDA Device · Class I · 2026-05-06 · Boston Scientific - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), M…
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079,…
FDA Device · Class II · 2026-05-06 · Philips North America - Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL…
FDA Device · Class I · 2026-05-06 · Boston Scientific - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V
FDA Device · Class II · 2026-05-06 · Medline Industries - Heraeus, PALAMIX duo
FDA Device · Class III · 2026-05-06 · Heraeus Medical Dental Division - Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA Device · Class II · 2026-05-06 · Healthmark Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ004592…
FDA Device · Class II · 2026-05-06 · Medline Industries - Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU…
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
FDA Device · Class II · 2026-05-06 · Medline Industries - Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc
FDA Device · Class II · 2026-05-06 · Medline Industries - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
FDA Device · Class II · 2026-05-06 · Medline Industries - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS8…
FDA Device · Class II · 2026-05-06 · Medline Industries - i-STAT EG7+ cartridge
FDA Device · Class II · 2026-05-06 · Abbott Point - Dimension Creatinine Flex reagent cartridge
FDA Device · Class II · 2026-05-06 · Siemens Healthcare Diagnostics - Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Descri…
FDA Device · Class II · 2026-05-06 · Clinical Innovations - Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113
FDA Device · Class II · 2026-05-06 · Philips North America - Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278
FDA Device · Class II · 2026-05-06 · Philips North America - Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF):…
FDA Device · Class II · 2026-05-06 · Philips North America - WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05
FDA Device · Class I · 2026-05-06 · Whill - Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11…
FDA Device · Class II · 2026-05-06 · Medline Industries - Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Device · Class II · 2026-05-06 · Elekta - Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130
FDA Device · Class II · 2026-05-06 · Philips North America - WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13
FDA Device · Class I · 2026-05-06 · Whill - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU D…
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 78139…
FDA Device · Class II · 2026-05-06 · Philips North America - Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M
FDA Device · Class II · 2026-05-06 · Medline Industries - Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112
FDA Device · Class II · 2026-05-06 · Philips North America - Heraeus, PALAMIX uno
FDA Device · Class III · 2026-05-06 · Heraeus Medical Dental Division - Straumann n!ce PMMA Full-arch Restoration
FDA Device · Class II · 2026-05-06 · Straumann Usa - Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203
FDA Device · Class II · 2026-05-06 · Depuy Ireland - Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (RE…
FDA Device · Class II · 2026-05-06 · Philips North America - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 1…
FDA Device · Class II · 2026-04-29 · Medline Industries - LeadCare¿ Plus Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ90…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C…
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
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)