Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
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.
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.
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc
Greiner Bio-One North America, Inc.
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnost
Abbott Molecular, Inc.
CVS PCSU SJH, REF SJCV48J
American Contract Systems, Inc.
S5-2 Transducer Probe
Philips Ultrasound, Inc
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer
Ortho-Clinical Diagnostics, INc.
HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
Stradis Medical, LLC dba Stradis Healthcare
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Intuitive Surgical, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for
Roche Diagnostics Operations, Inc.
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