RecallHawk

Medical Device Recalls

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

13,606 total recalls

1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscop

Stryker Corporation

AlluraXperFD20/15 System Code: (1) 722058

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2

CareFusion 303, Inc.

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intend

Siemens Medical Solutions USA, Inc

Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm

IHB OPERATIONS B.V.

ambIT Cassette Filter Male Luer, Product Code: 220266

Avanos Medical, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000023;

Beaver Visitec International, Inc.

Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield

TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L

American Contract Systems Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;

Beaver Visitec International, Inc.

ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators

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

Achieva 1.5T Initial, Magnetic Resonance System.

Philips North America Llc

STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril

Physio-Control, Inc.

3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

3M Company - Health Care Business

smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Unco

Smith & Nephew Inc

Intera 3.0T Quasar Dual, Model Number: 781150;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

SOMATOM Confidence -Computed tomography systems Model 10590100

Siemens Medical Solutions USA, Inc

Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

Ambu Inc.

ARTIS One Angiographic X-Ray System

SIEMENS MEDICAL SOLUTIONS USA, INC

Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog

Olympus Corporation of the Americas

KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from AT

Microbiologics Inc

Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION

MEDLINE INDUSTRIES, LP - Northfield

1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926

MEDLINE INDUSTRIES, LP - Northfield

WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal

Boston Scientific Corporation

FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

BioFire Diagnostics, LLC

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Bausch & Lomb Surgical, Inc.

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8

Volcano Corp

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

Becton Dickinson & Company

Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4.

Boston Scientific Corporation

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Beckman Coulter Inc.

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