Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 81 of 548
FDA Devices Critical Apr 24, 2024
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Philips Respironics, Inc.
FDA Devices Critical Apr 24, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Philips Respironics, Inc.
FDA Devices Moderate Apr 24, 2024
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Conformis, Inc.
FDA Devices Moderate Apr 24, 2024
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to …
Cook Incorporated
FDA Devices Moderate Apr 24, 2024
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Masimo Corporation
FDA Devices Moderate Apr 24, 2024
Ingenia Elition X, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Enterprise 1.5T, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE P…
Cook Incorporated
FDA Devices Moderate Apr 24, 2024
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications …
Cook Incorporated
FDA Devices Moderate Apr 24, 2024
MR 7700, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
GYROSCAN T5, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Achieva 3.0TX for PET, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) …
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 24, 2024
Intera CV, Magnetic Resonance System.
Philips North America Llc
FDA Devices Critical Apr 24, 2024
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc.
FDA Devices Moderate Apr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Masimo Corporation
FDA Devices Moderate Apr 24, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purp…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 24, 2024
Achieva 1.5T Conversion, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera 1.5T R11, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Achieva 1.5T Initial, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular appli…
Cook Incorporated
FDA Devices Moderate Apr 24, 2024
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Evolution Upgrade 3.0T, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 17, 2024
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who…
Boston Scientific Corporation
FDA Devices Critical Apr 17, 2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi USA, LLC
FDA Devices Moderate Apr 17, 2024
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applic…
Qiagen Sciences LLC
FDA Devices Moderate Apr 17, 2024
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/…
ConvaTec, Inc
FDA Devices Moderate Apr 17, 2024
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-00…
Synovo Production
FDA Devices Moderate Apr 17, 2024
Chromophare Surgical Light System , REF CH00000001
Stryker Communications
FDA Devices Moderate Apr 17, 2024
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE…
Baxter Healthcare Corporation
FDA Devices Moderate Apr 17, 2024
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Human Care Hc Sweden Ab
FDA Devices Moderate Apr 17, 2024
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients wh…
Boston Scientific Corporation
FDA Devices Moderate Apr 17, 2024
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who …
Boston Scientific Corporation
FDA Devices Moderate Apr 17, 2024
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Microbiologics Inc
CPSC Moderate Apr 11, 2024
Red Land Cotton Recalls Quilts and Shams Due to Laceration Hazard
Red Land Cotton, Moulton, Alabama
FDA Devices Moderate Apr 10, 2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314…
Exactech, Inc.
FDA Devices Moderate Apr 10, 2024
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Prod…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Apr 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Covidien, LP
FDA Devices Moderate Apr 10, 2024
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Apr 10, 2024
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic …
Life Technologies Corporation
FDA Devices Moderate Apr 10, 2024
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Karl Storz Endoscopy
FDA Devices Moderate Apr 10, 2024
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Abbott GmbH
FDA Devices Moderate Apr 10, 2024
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Apr 10, 2024
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
SleepNet Corporation
FDA Devices Moderate Apr 10, 2024
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Apr 10, 2024
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 4…
Exactech, Inc.
FDA Devices Moderate Apr 10, 2024
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Apr 10, 2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP
FDA Devices Moderate Apr 10, 2024
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Exactech, Inc.