Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F
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: LAPAROSCOPY COMBINED - NO NDL, Medli...
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.
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl...
Labeling: Incorrect or Missing Lot and/or Exp Date
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X...
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, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units)...
CGMP Deviations; deficiencies observed during FDA inspection
CANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12...
The product contains unapproved colors chlorophyll E140 and E141.
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medli...
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.
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 66...
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI...
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.
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Conn...
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured f...
CGMP Deviations; deficiencies observed during FDA inspection
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3...
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.
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: P...
CGMP Deviations; deficiencies observed during FDA inspection
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomyci...
CGMP Deviations; deficiencies observed during FDA inspection
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for...
CGMP Deviations; deficiencies observed during FDA inspection
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 ...
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.
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL...
Defective container:may contain bottles with incomplete seals
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured ...
CGMP Deviations; deficiencies observed during FDA inspection
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C ...
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.
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Act...
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-00...
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.
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 F...
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.