Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-04-26FDA-DeviceVerathon IncClass IIIt is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- 2017-04-26FDA-DeviceAlcon Research, Ltd.Class IIAlcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.
- 2017-04-26FDA-DeviceCOVIDIEN MEDTRONICClass IIValleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
Customer reports of the device handset continuing to operate after release of the activation button.
- 2017-04-26FDA-DeviceAce Surgical Supply Co., Inc.Class IIINFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Incorrect device was packaged.
- 2017-04-26FDA-DeviceSignal Medical CorporationClass IISoft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
- 2017-04-26FDA-DeviceBeckman Coulter Inc.Class IIAccess Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
- 2017-04-26FDA-DeviceInstradent USA, Inc.Class IINEODENT CM Intraoral Scanbody, Article Number: 108.139
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
- 2017-04-26FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, Proton Therapy System
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
- 2017-04-26FDA-DeviceTeleflex MedicalClass IIIArrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
- 2017-04-26FDA-DeviceMerge Healthcare, Inc.Class IIMerge Eye Station and Merge Eye Care PACS.
During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
- 2017-04-26FDA-DeviceFerno-Washington IncClass IIFerno PROFlexx¿ Model 28Z Chair Cot
The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
- 2017-04-26FDA-DeviceCordis CorporationClass IICordis S.M.A.R.T. Flex Vascular Stent System
Deployment Difficulty.
- 2017-04-26FDA-DeviceCincinnati Sub-Zero Products IncClass IIHemotherm CE, model 400CE, Heater-Cooling Device
Improperly rated fuses were used in the manufacture of the device.
- 2017-04-26FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee, Angiographic x-ray system
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
- 2017-04-26FDA-DeviceZimmer Dental IncClass IITapered SwissPlus Implant System, Model No. SPB10
It was manufactured with the minor diameter of the internal thread that is below specification.
- 2017-04-26FDA-DevicePhilips Electronics North America CorporationClass IIThe following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Ta
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief