RecallHawk

Medical Device Recalls

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

13,708 total recalls

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Stradis Healthcare

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

Stryker Corporation

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Intuitive Surgical, Inc.

MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.

Medline Industries, LP

ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators

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

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re

Ambu Inc.

Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

Abiomed, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter

Boston Scientific Corporation

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125

Becton Dickinson & Co.

JAGTOME RX 39-30-260-025 Material Number: M00573100

Boston Scientific Corporation

Senographe Pristina

GE Medical Systems, SCS

BD BBL TB Stain Kit K, Catalog (REF): 212522

Becton Dickinson & Co.

DeRoyal MYELOGRAM PACK, REF 89-9304.06

DeRoyal Industries Inc

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Boston Scientific Neuromodulation Corporation

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Reichert, Inc.

Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite

Olympus Corporation of the Americas

Thoraguard Chest Tube Kit, 20 Fr

Centese Inc.

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P

W L Gore & Associates, Inc.

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Cardinal Health 200, LLC

QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalacti

Microbiologics Inc

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Paragon 28, Inc.

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Ohio Medical Corporation

Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi

GE Medical Systems, LLC

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide

GE OEC Medical Systems, Inc

Revolution Apex, Revolution CT with Apex Edition

GE Healthcare, LLC

p-Chip Wand Reader

p-Chip Corporation

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following produ

Philips North America, LLC

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Siemens Medical Solutions USA, Inc

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