Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, Mi
Abbott Vascular
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
SunMed Holdings, LLC
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Waldemar Link GmbH & Co. KG (Mfg Site)
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GY
MEDLINE INDUSTRIES, LP - Northfield
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Covidien, LP
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack N
MEDLINE INDUSTRIES, LP - Northfield
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
B Braun Medical Inc
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011,
Exactech, Inc.
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3
Medline Industries, LP
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Biomet, Inc.
GS ENDOSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Baxter Healthcare Corporation
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT
Abbott Molecular, Inc.
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, La
LUMENIS, LTD.
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD
MEDLINE INDUSTRIES, LP - Northfield
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Flexicare Medical (Dongguan) Ltd.
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H
Boston Scientific Corporation
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended f
The Anspach Effort, Inc.
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A
Edwards Lifesciences, LLC
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System -
Aesculap Implant Systems LLC
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr
Philips Ultrasound, Inc.
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Draegerwerk Ag & Co. Kgaa
Philips 3D6-2 Ultrasound Transducer
Philips Ultrasound, Inc
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Busse Hospital Disposables, Inc.
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Ster
Medtronic Neurosurgery
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
ARROW INTERNATIONAL, LLC
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
Baxter Healthcare Corporation
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Cerapedics, Inc.
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