FDA medical device recalls

39,815 recall records. Showing the 50 most recent by initiation date.

Z-3035-2026 — POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting…Class II·Ongoing·Olympus Corporation of the Americas·20260818
Z-3066-2026 — Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLClass II·Ongoing·Baxter Healthcare Corporation·20260811
Z-3065-2026 — Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSClass II·Ongoing·Baxter Healthcare Corporation·20260811
Z-3086-2026 — 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3CClass II·Ongoing·Fresenius Medical Care Renal Therapies Group, LLC·20260810
Z-3085-2026 — 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Class II·Ongoing·Fresenius Medical Care Renal Therapies Group, LLC·20260810
Z-3084-2026 — 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Class II·Ongoing·Fresenius Medical Care Renal Therapies Group, LLC·20260810
Z-3087-2026 — 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Class II·Ongoing·Fresenius Medical Care Renal Therapies Group, LLC·20260810
Z-3112-2026 — Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3.…Class II·Ongoing·Atrium Medical Corporation·20260807
Z-3113-2026 — Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);Class II·Ongoing·Atrium Medical Corporation·20260807
Z-3111-2026 — Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28F…Class II·Ongoing·Atrium Medical Corporation·20260807
Z-3040-2026 — Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Co…Class II·Ongoing·Philips North America Llc·20260807
Z-3041-2026 — Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.xClass II·Ongoing·Philips North America Llc·20260807
Z-3042-2026 — Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elit…Class II·Ongoing·Philips North America Llc·20260807
Z-3043-2026 — Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232.…Class II·Ongoing·Philips North America Llc·20260807
Z-3090-2026 — Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product…Class I·Ongoing·Given Imaging Ltd.·20260806
Z-3110-2026 — Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energ…Class II·Ongoing·Lutronic Corporation·20260806
Z-3082-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Ver…Class II·Ongoing·Boston Scientific Corporation·20260806
Z-3083-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Ve…Class II·Ongoing·Boston Scientific Corporation·20260806
Z-3081-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver…Class II·Ongoing·Boston Scientific Corporation·20260806
Z-3034-2026 — ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600Class II·Ongoing·IMRIS Imaging Inc·20260806
Z-3033-2026 — ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the…Class II·Ongoing·IMRIS Imaging Inc·20260806
Z-3135-2026 — Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Class II·Ongoing·Nipro Renal Soultions USA, Corporation·20260805
Z-3134-2026 — MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Class II·Ongoing·Nipro Renal Soultions USA, Corporation·20260805
Z-3136-2026 — Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Class II·Ongoing·Nipro Renal Soultions USA, Corporation·20260805
Z-3133-2026 — MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Class II·Ongoing·Nipro Renal Soultions USA, Corporation·20260805
Z-3089-2026 — Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025Class II·Ongoing·B Braun Medical Inc·20260804
Z-3014-2026 — Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a…Class II·Ongoing·Canon Medical System, USA, INC.·20260804
Z-3064-2026 — HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10…Class II·Ongoing·Johnson & Johnson Surgical Vision, Inc.·20260731
Z-2872-2026 — BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D01525…Class I·Ongoing·Bard Access Systems, Inc.·20260730
Z-3138-2026 — AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BClass II·Ongoing·Windstone Medical Packaging, Inc.·20260729
Z-3098-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3094-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3096-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3097-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3101-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3105-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3100-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3104-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3099-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIA…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3102-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3095-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3103-2026 — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KI…Class II·Ongoing·Cardinal Health 200, LLC·20260729
Z-3047-2026 — STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor defi…Class II·Ongoing·Diagnostica Stago, Inc.·20260729
Z-3032-2026 — healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001Class II·Ongoing·Healthmark Industries Co., Inc.·20260729
Z-3031-2026 — healthmark ProChek-II, Model Number PT-313, PT-201-12Class II·Ongoing·Healthmark Industries Co., Inc.·20260729
Z-3120-2026 — HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (…Class II·Ongoing·HeartSine Technologies Ltd·20260727
Z-2940-2026 — Ami HTXClass II·Ongoing·Spectral Instruments Inc·20260724
Z-2939-2026 — Lago XClass II·Ongoing·Spectral Instruments Inc·20260724
Z-3106-2026 — Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampulesClass I·Ongoing·Medical Action Industries, Inc. 306·20260723
Z-3107-2026 — Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride…Class I·Ongoing·Medical Action Industries, Inc. 306·20260723