United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfa...
CGMP Deviations; deficiencies observed during FDA inspection
Dairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box
Potential for Salmonella
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) ...
Due to 11 volt Backup Battery failures.
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination ...
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.
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical...
Potential for overpressure alerts.
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Automated Impella Controller (AIC), for use with left heart support blood pump. ...
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
Medline convenience kits: DAVINCI MAIN DYNJ908031D
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulf...
CGMP Deviations; deficiencies observed during FDA inspection
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Ca...
Crystallization; identified as Buprenorphine free base
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured f...
CGMP Deviations; deficiencies observed during FDA inspection
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Act...
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flav...
Defective container:may contain bottles with incomplete seals
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Acti...
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo...
Defective container:may contain bottles with incomplete seals
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt...
CGMP Deviations; deficiencies observed during FDA inspection
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl...
Labeling: Incorrect or Missing Lot and/or Exp Date
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for:...
CGMP Deviations; deficiencies observed during FDA inspection
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL...
Defective container:may contain bottles with incomplete seals