Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047;
GE Healthcare
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Stryker Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovasc
Boston Scientific Corporation
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa
Siemens Healthcare Diagnostics Inc
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Te
Stradis Healthcare
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85
Atrium Medical Corporation
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Encore Medical, LP
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Howmedica Osteonics Corp.
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Allergan Sales, LLC
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Zeltiq Aesthetics, Inc
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa
B Braun Medical Inc
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte
Ethicon Endo-Surgery Inc
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAG
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001382;
Beaver Visitec International, Inc.
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P
Medtronic Neuromodulation
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusio
Covidien Llc
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/
Vyaire Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; N
Aesculap Implant Systems LLC
SM_40HF_BDC, Mobile X-ray system
SEDECAL SA
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P
Integra LifeSciences Corp. (NeuroSciences)
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 13
Exactech, Inc.
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics, Inc.
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
MEDLINE INDUSTRIES, LP - Northfield
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows
Stryker Corporation
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
TELEFLEX LLC
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709
Respironics California, LLC
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cyst
Scholly Fiberoptic Gmbh
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT P
B. Braun Medical, Inc.
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