Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Soft
Kico Knee Innovation Company
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Reichert, Inc.
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Baxter Healthcare Corporation
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN
TruAbutment Inc.
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Philips North America
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
MEDLINE INDUSTRIES, LP - Northfield
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s
Community Products, LLC
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Philips North America Llc
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE,
MEDLINE INDUSTRIES, LP - Northfield
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Oakworks Inc
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K rewo
Convergent Dental
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use
Integra LifeSciences Corp.
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicat
Mckesson Medical-Surgical Inc. Corporate Office
Burlington Medical, Protective Sleeves.
Burlington Medical, LLC
Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Nu
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes
Jiangsu Shenli Medical Production Co., Ltd.
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Covidien LP
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
ROi CPS LLC
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONAR
Medline Industries, LP
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Olympus Corporation of the Americas
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Bard Peripheral Vascular Inc
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).
GE Medical Systems, LLC
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla
Waldemar Link GmbH & Co. KG (Mfg Site)
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Cata
Howmedica Osteonics Corp.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Pr
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
MEDLINE INDUSTRIES, LP - Northfield
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Cook Medical Incorporated
ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
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