All recalls8,424 total
Product contains undeclared Yellow No. 5.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Temperature probe devices lack FDA clearance.
Temperature probe devices lack FDA clearance.
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Due to stain present on the surface of affected foley catheters.
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Temperature probe devices lack FDA clearance.
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product has the potential to be contaminated with Salmonella.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Lack of assurance of Sterility: potential product contamination
Lack of assurance of Sterility: potential product contamination
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
Contamination to in-vitro diagnostic test may result in false positives.
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.
Undeclared allergens (wheat and soy).
Foreign object: metal pieces
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Certain lots of product have the potential for a sterile barrier breach.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.