FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 17 of 520
Moderate Oct 22, 2025
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instr…
Iantrek Inc.
Moderate Oct 22, 2025
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS9…
American Contract Systems Inc.
Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Olympus Corporation of the Americas
Critical Oct 22, 2025
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-4…
Cook Medical Incorporated
Moderate Oct 22, 2025
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Fisher & Paykel Healthcare, Ltd.
Critical Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Olympus Corporation of the Americas
Moderate Oct 22, 2025
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis devic…
Iantrek Inc.
Critical Oct 22, 2025
Model Number L121 ESSENTIO DR EL Pacemaker
Boston Scientific Corporation
Moderate Oct 22, 2025
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
GE Medical Systems, LLC
Moderate Oct 22, 2025
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROS…
American Contract Systems Inc.
Critical Oct 22, 2025
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Boston Scientific Corporation
Moderate Oct 22, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Prod…
Baxter Healthcare Corporation
Critical Oct 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Olympus Corporation of the Americas
Critical Oct 15, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
NOXBOX LTD
Critical Oct 15, 2025
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10…
CareFusion 303, Inc.
Moderate Oct 15, 2025
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated f…
Canon Medical System, USA, INC.
Moderate Oct 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX …
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
GE Medical Systems, SCS
Moderate Oct 15, 2025
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Nee…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needl…
B BRAUN MEDICAL INC
Critical Oct 15, 2025
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Co…
Abiomed, Inc.
Moderate Oct 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX F…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
CORNEAT VISION, LTD.
Moderate Oct 15, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed th…
Applied Medical Technology Inc
Moderate Oct 15, 2025
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
ImaCor Inc.
Moderate Oct 15, 2025
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spin…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
CORNEAT VISION, LTD.
Moderate Oct 15, 2025
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Inpeco S.A.
Moderate Oct 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Cathet…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Spr…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIES…
B BRAUN MEDICAL INC
Moderate Oct 15, 2025
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Inpeco S.A.
Moderate Oct 8, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Medtronic MiniMed, Inc.
Critical Oct 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…
Siemens Medical Solutions USA, Inc
Critical Oct 8, 2025
Biograph mMR. Model Number: 10433372.
Siemens Medical Solutions USA, Inc
Moderate Oct 8, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT…
North American Rescue LLC.
Moderate Oct 8, 2025
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…
Northeast Scientific Inc.
Moderate Oct 8, 2025
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathe…
Northeast Scientific Inc.
Moderate Oct 8, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Man…
MedicalCommunications GmbH
Moderate Oct 8, 2025
ZAP-X Radiosurgery System, Model: 300150
Zap Surgical Systems
Critical Oct 8, 2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an an…
Draeger, Inc.
Critical Oct 8, 2025
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165…
Medline Industries, LP
Moderate Oct 8, 2025
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Aesculap AG
Moderate Oct 8, 2025
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…
Northeast Scientific Inc.
Moderate Oct 8, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 8, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Getinge Disinfection Ab
Moderate Oct 8, 2025
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Schiller, Ag
Critical Oct 8, 2025
MAGNETOM Verio. Model Number: 10276755.
Siemens Medical Solutions USA, Inc