RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,600 total recalls

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Erbe USA Inc

RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant com

Encore Medical, LP

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

ConMed Corporation

Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pac

MEDLINE INDUSTRIES, LP - Northfield

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095

TELEFLEX LLC

TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend po

Stryker Medical Division of Stryker Corporation

VentStar Watertrap (P) 180 w/oLL, MP00362

Draeger Medical, Inc.

Accula SARS-CoV-2 Test, REF: COV4100

MESA BIOTECH, INC

Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, Y

YAMAHA MOTOR CORPORATION

IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 U

Siemens Healthcare Diagnostics, Inc.

AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

Boston Scientific Corporation

Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, P

MEDLINE INDUSTRIES, LP - Northfield

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS

ReCor Medical Inc.

Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

Philips North America

Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number

MEDLINE INDUSTRIES, LP - Northfield

Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.

Onkos Surgical, Inc.

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

Ortho-Clinical Diagnostics, Inc.

Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4

Corin Ltd

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. Fo

Cook Incorporated

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

Smiths Medical ASD Inc.

Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34

AVID Medical, Inc.

VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). F

Angiodynamics, Inc.

ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform.

Becton Dickinson & Co.

11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC

Karl Storz Endoscopy

Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

Covidien, LP

(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human

MEDLINE INDUSTRIES, LP - Northfield

Product Name: Upgrade to MR 7700; Model Number: 782130;

Philips North America Llc

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

IDS LTD

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