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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