All Recalls

95,089 total recalls in our database

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Oct 5, 2016 Diagnostic Equipment Nationwide View Details β†’

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.

Jul 4, 2016 Implants & Prosthetics Nationwide View Details β†’

The EP Catheters may be mislabeled for French size during reprocessing.

Oct 6, 2016 Diagnostic Equipment View Details β†’

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.

Oct 11, 2016 Surgical Instruments View Details β†’

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.

Sep 27, 2016 Surgical Instruments Nationwide View Details β†’

catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405624 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405634 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405636 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405641 BD Spinal Anesthesia Tray 24G x 3.5 in. SprotteΒΏ Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405648 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog# 405649 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405682 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405684 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405685 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog#405694 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405704 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405737 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) catalog# 405829 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW

Becton Dickinson & Company

πŸ₯ Medical Devices Class I - Dangerous

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.

Aug 2, 2016 Surgical Instruments Nationwide View Details β†’

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.

Sep 29, 2016 Surgical Instruments View Details β†’

Children's shoes

Unknown Manufacturer

🏠 Consumer Products Class III - Low Risk

The rivets on the shoes have sharp edges, posing a laceration hazard.

Nov 16, 2016 Children's Products Nationwide View Details β†’

ATV and UTV clutches

Gates Canada Inc., of Canada

🏠 Consumer Products Class III - Low Risk

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.

Nov 15, 2016 Clothing & Accessories Nationwide View Details β†’

Projection night lights

Wenzhou Weihao Light Industry Co. LTD, of China

🏠 Consumer Products Class I - Dangerous

The night lights can short circuit, posing shock and fire hazard to consumers.

Nov 15, 2016 Clothing & Accessories Nationwide View Details β†’

Fun-karts

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The fuel tank can crack and cause the fuel to leak out, posing a fire hazard.

Nov 14, 2016 Other Consumer Products Nationwide View Details β†’
🏠 Consumer Products Class I - Dangerous

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.

Nov 10, 2016 Children's Products Nationwide View Details β†’

Krystal Ice ceiling fixtures

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

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.

Nov 10, 2016 Other Consumer Products Nationwide View Details β†’

The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.

Oct 11, 2016 Other Foods Nationwide View Details β†’