United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
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.
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.
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445052...
Due to unsealed portions of pouches.
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.
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSC...
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.
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cyst...
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: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT:...
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: 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.
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA ...
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 Urethral Catheterization Tray, Red Rubber Latex, Medline Product 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 8mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
Medline convenience kits: PORT A CATH DYNJ906818A
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" System Controller Model/Catal...
Due to 11 volt Backup Battery failures.
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.
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfa...
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.
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Pr...
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
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.
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CV...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)...
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.
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomyci...
CGMP Deviations; deficiencies observed during FDA inspection
HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/S...
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.
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo...
Defective container:may contain bottles with incomplete seals