Safety Recall Directory
Browse and filter the latest official safety alerts globally.
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical...
Potential for overpressure alerts.
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo...
Defective container:may contain bottles with incomplete seals
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-...
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.
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with In...
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt...
CGMP Deviations; deficiencies observed during FDA inspection
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Ca...
Due to 11 volt Backup Battery failures.
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM ...
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.
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
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.
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical T...
Potential for overpressure alerts.
Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU D...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
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.
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Ma...
CGMP Deviations; deficiencies observed during FDA inspection
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ6...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Me...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sen...
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
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.
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, A...
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.
Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIA...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K B...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.