All Recalls

95,038 total recalls in our database

Healix Knotless ADV BR 5.5 Suture Anchor

DePuy Mitek, Inc., a Johnson & Johnson

πŸ₯ Medical Devices Class I - Dangerous

Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDEΒΏ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.

Nov 4, 2019 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

Oct 30, 2019 Surgical Instruments View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details β†’

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Oct 28, 2019 Surgical Instruments View Details β†’
🏠 Consumer Products Class I - Dangerous

The chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-17).

Dec 18, 2019 Furniture Nationwide View Details β†’
🏠 Consumer Products Class II - Moderate

Small stones can be present in the pockets or waistband of the pants from the stone washing manufacturing process, posing aspiration or choking hazards to young children.

Dec 17, 2019 Clothing & Accessories Nationwide View Details β†’