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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