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.

• CRE Pro Wireguided 8-10mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialy…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473
  FDA Device · Class I · 2026-07-08 · Baxter Healthcare
• Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Pr…
  FDA Device · Class II · 2026-07-08 · Medela
• SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
  FDA Device · Class II · 2026-07-08 · Mentor Texas
• Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVE…
  FDA Device · Class II · 2026-07-08 · Medline Industries
• OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 01108854031083…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators
  FDA Device · Class I · 2026-07-08 · Hamilton Medical Ag
• 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tis…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L
  FDA Device · Class II · 2026-07-08 · Medline Industries
• CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 008…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code:…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
  FDA Device · Class II · 2026-07-08 · Medline Industries
• CRE Pro Wireguided 10-12mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• Omnipod (Eros) Pod
  FDA Device · Class I · 2026-07-08 · Insulet
• CRE Wireguided 18-20mm 240cm
  FDA Device · Class II · 2026-07-08 · Boston Scientific
• 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 da…
  FDA Device · Class II · 2026-07-08 · Bard Access Systems
• Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995
  FDA Device · Class II · 2026-07-08 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• GE Healthcare AW Server 3.2 ext.6.5
  FDA Device · Class II · 2026-07-01 · Ge Medical Systems Scs
• Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
  FDA Device · Class II · 2026-07-01 · Philips North America
• Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
  FDA Device · Class II · 2026-07-01 · Zimmer
• Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890
  FDA Device · Class I · 2026-07-01 · Medline Industries
• Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Multi-Snare Set: 5 mm x 125 cm, REF: 147305
  FDA Device · Class II · 2026-07-01 · Pfm Medical
• Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
  FDA Device · Class II · 2026-07-01 · Zimmer
• Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
  FDA Device · Class II · 2026-07-01 · Zimmer
• Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Da Vinci ASSY, PSS, SP1098, Part Number: 380601
  FDA Device · Class II · 2026-07-01 · Intuitive Surgical
• Octopus 4 Tissue Stabilizer, Model 29400
  FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems
• Octopus Evolution Tissue Stabilizer, Model TS2000
  FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems
• Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number…
  FDA Device · Class II · 2026-07-01 · Dexcom
• Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232
  FDA Device · Class II · 2026-07-01 · Philips North America
• Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q
  FDA Device · Class I · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• TMJ Bilateral Implants, REF: CHG020
  FDA Device · Class II · 2026-07-01 · Tmj Solutions
• Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
  FDA Device · Class II · 2026-07-01 · Boston Scientific
• Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
  FDA Device · Class II · 2026-07-01 · Philips North America
• Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435
  FDA Device · Class I · 2026-07-01 · Abiomed
• Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434
  FDA Device · Class I · 2026-07-01 · Abiomed
• Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits
  FDA Device · Class I · 2026-07-01 · Abiomed
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan
  FDA Device · Class I · 2026-07-01 · Abiomed
• Octopus Evolution AS Tissue Stabilizer, Model TS2500
  FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Thuvera Laser Console
  FDA Device · Class II · 2026-07-01 · Ipg Medical
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP
  FDA Device · Class I · 2026-07-01 · Medline Industries
• Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• INZONE DETACHMENT SYSTEM, REF: M00345100950
  FDA Device · Class II · 2026-07-01 · Stryker Neurovascular
• Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142
  FDA Device · Class I · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10…
  FDA Device · Class II · 2026-07-01 · Zimmer
• Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw
  FDA Device · Class II · 2026-07-01 · Acumed
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• VOCSN+Pro package, REF: PRT-00853-000
  FDA Device · Class II · 2026-07-01 · Ventec Life Systems
• Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
  FDA Device · Class II · 2026-07-01 · Zimmer
• Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
  FDA Device · Class II · 2026-07-01 · Zimmer
• Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1
  FDA Device · Class II · 2026-07-01 · Surgify Medical Oy
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
  FDA Device · Class II · 2026-07-01 · Medline Industries
• ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length
  FDA Device · Class II · 2026-06-24 · Conmed
• Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYN…
  FDA Device · Class II · 2026-06-24 · Medline Industries
• Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B AC…
  FDA Device · Class II · 2026-06-24 · Medline Industries
• TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400
  FDA Device · Class II · 2026-06-24 · Howmedica Osteonics
• Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is desi…
  FDA Device · Class II · 2026-06-24 · Staar Surgical Ag
• Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40…
  FDA Device · Class II · 2026-06-24 · Medline Industries
• MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C
  FDA Device · Class II · 2026-06-24 · Medline Industries
• MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
  FDA Device · Class II · 2026-06-24 · Medline Industries
• MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr
  FDA Device · Class II · 2026-06-24 · Medline Industries
• Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC
  FDA Device · Class I · 2026-06-24 · Arrow International
• Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING C…
  FDA Device · Class II · 2026-06-24 · Medline Industries
• Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
  FDA Device · Class II · 2026-06-24 · Medline Industries
• ALYON Surgical Lighting System
  FDA Device · Class II · 2026-06-24 · Steris
• TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300
  FDA Device · Class II · 2026-06-24 · Howmedica Osteonics
• Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
  FDA Device · Class I · 2026-06-24 · Arrow International
• MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
  FDA Device · Class II · 2026-06-24 · Medline Industries

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)