Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump
B. Braun Medical, Inc.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe
Medline Industries, LP
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjus
Community Products, LLC
IQon Spectral CT; Product Code (REF): 728332;
Philips North America Llc
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)
Integra LifeSciences Corp.
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200
Philips Respironics, Inc.
MRI system: Vantage Elan, Model: MRT-2020
Canon Medical System, USA, INC.
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Shirakawa Olympus Co., Ltd.
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Medtronic MiniMed, Inc.
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b.
Mckesson Medical-Surgical Inc. Corporate Office
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT
MEDLINE INDUSTRIES, LP - Northfield
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5
ICU Medical Inc.
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced t
Spineology, Inc.
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Bolton Medical Inc.
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in
Windstone Medical Packaging, Inc.
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Unetixs Vascular, Inc.
Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile sy
Jiangsu Shenli Medical Production Co., Ltd.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medtronic Inc.
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Numbe
MEDLINE INDUSTRIES, LP - Northfield
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm,
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
IntelliVue Patient Monitor MX100. Product Number: 867033.
Philips North America Llc
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model
Medline Industries, LP
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT
Medtronic Inc.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance
GE Healthcare, LLC
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE
Medline Industries, LP
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Philips North America
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in prote
Integra LifeSciences Corp.
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
Boston Scientific Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001795;
Beaver Visitec International, Inc.
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