Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
IntelliVue MP80. Product Number: M8008A.
Philips North America Llc
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patie
Welch Allyn Inc
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy
Philips North America Llc
MAGNETOM Skyra fit. Model Number: 10849580.
Siemens Medical Solutions USA, Inc
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Steri
Jiangsu Shenli Medical Production Co., Ltd.
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
SCIENCE & BIO MATERIALS
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Umano Medical, Inc.
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
TELEFLEX LLC
DeRoyal LAMI/CRANI PACK, REF 89-10787.01
DeRoyal Industries Inc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate
Philips North America Llc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Tornier, Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
B Braun Medical Inc
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Cardinal Health 200, LLC
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec
Avanos Medical, Inc.
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue
Artivion, Inc
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1),
Dexcom, Inc.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI
Shanghai United Imaging Healthcare Co., Ltd.
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Staar Surgical Company
GEM Premier 5000 PAK; Part No. 00055360008.
Instrumentation Laboratory
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Cook Incorporated
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
AVID Medical, Inc.
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Universal Meditech Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgica
DePuy Orthopaedics, Inc.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Zimmer, Inc.
Thermalon Neck Wrap, Item Number 24322
Bruder Healthcare Company, LLC
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Cook Incorporated
dS Breast 7ch 3.0T
Philips North America Llc
Heraeus, PALAMIX duo. Material Number: 66057897.
Heraeus Medical GmbH (Dental Division)
GYN LAPAROSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
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