Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 5 of 548
FDA Devices Moderate Jan 14, 2026
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. …
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Jan 14, 2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc
CPSC Moderate Jan 8, 2026
Isla Rae Magnetic Wireless Chargers Recalled Due to Fire and Burn Hazards; Sold by TJX at T.J. Maxx and Marshalls Stores
The TJX Companies Inc., of Framingham, Massachusetts
FDA Devices Moderate Jan 7, 2026
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Beaver-Visitec International, Inc.
FDA Devices Moderate Jan 7, 2026
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Vortex Surgical Inc.
FDA Devices Moderate Jan 7, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF…
Philips Ultrasound, LLC
FDA Devices Moderate Jan 7, 2026
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial…
Ferndale Laboratories, Inc.
FDA Devices Moderate Jan 7, 2026
Material Processing Laser Products
SHENZHEN ATOMSTACK TECHNOLOGIES
FDA Devices Moderate Jan 7, 2026
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, …
Sheathing Technologies Inc
FDA Devices Moderate Dec 31, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-…
CareFusion 303, Inc.
FDA Devices Moderate Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900…
Medtronic Neuromodulation
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
ICU Medical, Inc.
FDA Devices Moderate Dec 31, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diod…
Howmedica Osteonics Corp.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: …
Zimmer, Inc.
FDA Devices Critical Dec 31, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Draeger, Inc.
FDA Devices Moderate Dec 31, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-…
Cook Incorporated
FDA Devices Moderate Dec 31, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Diasol, Inc
FDA Devices Moderate Dec 31, 2025
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Intuitive Surgical, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
ICU Medical, Inc.
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 31, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare Corp.
FDA Devices Moderate Dec 31, 2025
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for tran…
Cook Incorporated
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Cepheid
FDA Devices Moderate Dec 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Smith & Nephew, Inc.
FDA Devices Low Dec 24, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory
FDA Devices Moderate Dec 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Zimmer Surgical Inc
FDA Devices Moderate Dec 24, 2025
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 1…
Mindray DS USA, Inc. dba Mindray North America
FDA Devices Moderate Dec 24, 2025
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
PATH
FDA Devices Moderate Dec 24, 2025
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (s…
Myofunctional Research Company USA
FDA Devices Moderate Dec 24, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories
FDA Devices Moderate Dec 24, 2025
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
AVID Medical, Inc.
FDA Devices Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product D…
Rocket Medical Plc
FDA Devices Moderate Dec 24, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE Healthcare GmbH
FDA Devices Moderate Dec 24, 2025
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
AVID Medical, Inc.
FDA Devices Low Dec 24, 2025
Cardiosave Rescue
Datascope Corp.
FDA Devices Critical Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012…
GE Medical Systems China Co., Ltd.
FDA Devices Moderate Dec 24, 2025
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 5…
DSAART LLC