RecallHawk

Medical Device Recalls

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

13,640 total recalls

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-

Fresenius Kabi USA, LLC

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version:

Alcon Research LLC

BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433

CAREFUSION

Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL

Stryker Corporation

Achieva 3.0T, Magnetic Resonance System.

Philips North America Llc

Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

Hobbs Medical, Inc.

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators

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

PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

AMD Medicom Inc.

Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d.

MEDLINE INDUSTRIES, LP - Northfield

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR reade

Landauer

Medicina Oral Tip Syringe 0.5ml Code: OT005

Medicina Uk Ltd

Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA

MEDLINE INDUSTRIES, LP - Northfield

Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF,

Medline Industries, LP

sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carb

SenTec AG

Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP,

WASATCH PHOTONICS

Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140

C.R. Bard Inc

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controll

mo-Vis BVBA

STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medica

Scican Ltd.

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Pro

Philips North America Llc

DeRoyal CANNULTED HIP PACK, REF 89-6977.10

DeRoyal Industries Inc

Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x

CareFusion 303, Inc.

basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C

Merit Medical Systems, Inc.

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19

Olympus Corporation of the Americas

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Nu

Hologic, Inc

Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Nu

MEDLINE INDUSTRIES, LP - Northfield

VentStar Basic (P)180, MP00351

Draeger Medical, Inc.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number

Medline Industries, LP

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Staar Surgical Company

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