Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
All Recalls
95,089 total recalls in our database
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.
The EP Catheters may be mislabeled for French size during reprocessing.
SOMATOM Definition Flash system, x-ray, tomography, computed
Siemens Medical Solutions USA
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Children's shoes
Unknown Manufacturer
The rivets on the shoes have sharp edges, posing a laceration hazard.
ATV and UTV clutches
Gates Canada Inc., of Canada
The clutch can break during operation of the vehicle and cause fragmentation and forcefully eject parts, posing laceration or impact injury hazards to the operator.
Projection night lights
Wenzhou Weihao Light Industry Co. LTD, of China
The night lights can short circuit, posing shock and fire hazard to consumers.
Fun-karts
Unknown Manufacturer
The fuel tank can crack and cause the fuel to leak out, posing a fire hazard.
Kidde NightHawk combination smoke/carbon monoxide (CO) alarms
Unknown Manufacturer
The alarm can fail to continue to chirp when it reaches its 7-year end of life if the batteries are replaced, leading consumers to believe it is still working. This poses a risk of consumers not being alerted to a fire or CO incident in their home.
Krystal Ice ceiling fixtures
Unknown Manufacturer
The 40-watt halogen bulbs sold with the ceiling fixtures burn too hot for the electrical supply wires in the ceiling, posing a fire hazard. The fixtures also pose a fire hazard in homes with older wiring, even if used with lower wattage bulbs.
The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.
The Stone Ground Peanut Butter Chocolate Bar is recalled due to undeclared soy lecithin.
7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 --
Glenn Wayne Wholseale Bakery
The finished cookie product may contain undeclared peanuts.
Hollandaise Sauce was recalled due to presence of mold.
7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE, NET WT. 4 OZ., UPC 052548558758; Manhattan UPC: 052548570651
Glenn Wayne Wholseale Bakery
The finished cookie product may contain undeclared peanuts.