FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 31 of 520
Critical May 21, 2025
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Baxter Healthcare Corporation
Moderate May 21, 2025
Intera 3.0T Quasar Dual, Model Number: 781150;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate May 21, 2025
Intera 1.5T Power/Pulsar, Model Number: 781105;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical May 21, 2025
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Medical Depot Inc.
Moderate May 21, 2025
Intera 1.5T R11, Model Number: 781170;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate May 14, 2025
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Ped…
Philips North America Llc
Critical May 14, 2025
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…
Smiths Medical ASD, Inc.
Moderate May 14, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Philips Medical Systems Nederland B.V.
Moderate May 14, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Remote Diagnostic Technologies Ltd.
Moderate May 14, 2025
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation insti…
WANDERCRAFT SAS
Critical May 14, 2025
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…
Smiths Medical ASD, Inc.
Moderate May 14, 2025
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other intervent…
Galt Medical Corporation
Critical May 14, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Integra LifeSciences Corp. (NeuroSciences)
Critical May 14, 2025
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…
Smiths Medical ASD, Inc.
Moderate May 14, 2025
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introd…
Galt Medical Corporation
Critical May 14, 2025
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…
Smiths Medical ASD, Inc.
Moderate May 14, 2025
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Integra LifeSciences Corp. (NeuroSciences)
Moderate May 14, 2025
Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon
Moderate May 14, 2025
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
MEDLINE INDUSTRIES, LP - Northfield
Critical May 14, 2025
CADD Solis HSPCA Pump
Smiths Medical ASD, Inc.
Moderate May 14, 2025
Washer Disinfector Aquadis 56; Model Number: 56M
Getinge Disinfection Ab
Moderate May 14, 2025
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indica…
Galt Medical Corporation
Moderate May 14, 2025
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
SCIENCE & BIO MATERIALS
Moderate May 14, 2025
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Tornier S.A.S.
Critical May 14, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Bausch & Lomb Surgical, Inc.
Moderate May 14, 2025
Washer Disinfector Aquadis 56; Model Number: 56A
Getinge Disinfection Ab
Critical May 7, 2025
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
GE Medical Systems China Co., Ltd.
Critical May 7, 2025
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
GE Medical Systems China Co., Ltd.
Moderate May 7, 2025
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 …
Belmont Instrument LLC
Moderate May 7, 2025
myQA iON; Article Number: MQ10-000;
IBA Dosimetry GmbH
Moderate May 7, 2025
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cement…
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate May 7, 2025
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md…
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate May 7, 2025
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French langua…
Defibtech, LLC
Critical May 7, 2025
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
GE Medical Systems China Co., Ltd.
Moderate May 7, 2025
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Fr…
Boston Scientific Corporation
Moderate May 7, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4…
Beckman Coulter Inc.
Moderate May 7, 2025
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
MEDLINE INDUSTRIES, LP - Northfield
Moderate May 7, 2025
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF D…
MEDLINE INDUSTRIES, LP - Northfield
Moderate May 7, 2025
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
MEDLINE INDUSTRIES, LP - Northfield
Critical May 7, 2025
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
GE Medical Systems China Co., Ltd.
Moderate May 7, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
MEDLINE INDUSTRIES, LP - Northfield
Moderate May 7, 2025
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Free…
Boston Scientific Corporation
Moderate May 7, 2025
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
MEDLINE INDUSTRIES, LP - Northfield
Critical May 7, 2025
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
GE Medical Systems China Co., Ltd.
Critical May 7, 2025
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
GE Medical Systems China Co., Ltd.
Critical May 7, 2025
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
GE Medical Systems China Co., Ltd.
Moderate May 7, 2025
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual …
Defibtech, LLC
Critical May 7, 2025
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
GE Medical Systems China Co., Ltd.
Moderate May 7, 2025
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description:…
Spectrum Medical Ltd.
Moderate May 7, 2025
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configura…
Siemens Healthcare Diagnostics Inc