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 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 - Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
FDA Device · Class II · 2026-04-29 · Medline Industries - Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
FDA Device · Class II · 2026-04-29 · Micro X - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLU…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE T…
FDA Device · Class II · 2026-04-29 · Medline Industries - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DY…
FDA Device · Class II · 2026-04-29 · Medline Industries - Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm
FDA Device · Class II · 2026-04-29 · Olympus - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - LeadCare Ultra Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Soft -Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - 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 ARTHROSCOPY PACK DYNJ45173D
FDA Device · Class II · 2026-04-29 · Medline Industries - AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics - Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm
FDA Device · Class II · 2026-04-29 · Olympus - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66…
FDA Device · Class II · 2026-04-29 · Medline Industries - Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
FDA Device · Class II · 2026-04-29 · Windstone Medical Packaging - ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH…
FDA Device · Class II · 2026-04-29 · Arrow International - Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
FDA Device · Class II · 2026-04-29 · Remel Europe - Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Access Total T4 Calibrator, Catalog No. 33805
FDA Device · Class II · 2026-04-29 · Beckman Coulter - Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
FDA Device · Class II · 2026-04-29 · Medline Industries - Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
FDA Device · Class II · 2026-04-29 · Windstone Medical Packaging - Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics - LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Device · Class II · 2026-04-29 · Lsl Healthcare - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
FDA Device · Class II · 2026-04-29 · Diversatek Healthcare - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCO…
FDA Device · Class II · 2026-04-29 · Medline Industries - OER-ELITE Endoscope Reprocessor Connecting Tubes
FDA Device · Class II · 2026-04-29 · Olympus - Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
FDA Device · Class II · 2026-04-29 · Medline Industries - PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352…
FDA Device · Class II · 2026-04-29 · Arrow International
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)