RecallHawk

Medical Device Recalls

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

13,640 total recalls

OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Boston Scientific Corporation

HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr

Hamilton Medical, Inc.

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Mod

North American Rescue LLC.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11

Linkbio Corp.

A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the di

Tyber Medical

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

Masimo Corporation

Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

Jiangsu Shenli Medical Production Co., Ltd.

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inact

Microbiologics Inc

WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel

WHILL, INC.

Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

Biomet, Inc.

Radiography 7300 C; Model Number: 712037;

Philips Medical Systems DMC GmbH

STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-

Karl Storz Endoscopy

DeRoyal FOOT PACK, REF 89-9252.08

DeRoyal Industries Inc

DeRoyal PAIN TRAY, REF 89-10464.03

DeRoyal Industries Inc

Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper

Lumicell, Inc.

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

Terumo Cardiovascular Systems Corporation

MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;

Beaver Visitec International, Inc.

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 810

Sol-Millennium Medical Inc.

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe

Midmark Corporation

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Merit Medical Systems, Inc.

MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

GE Healthcare, LLC

CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators

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

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

AVID Medical, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

Datascope Corp.

HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089

Stradis Medical, LLC dba Stradis Healthcare

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

LAVH, REF BBLV21C

American Contract Systems, Inc.

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip

Zimmer, Inc.

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