United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
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.
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIM...
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.
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.
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 unit...
CGMP Deviations; deficiencies observed during FDA inspection
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM ...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Man...
Defective container:may contain bottles with incomplete seals
Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHO...
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.
Harbinger Motors Inc. - Loose Steering Gear Mounting Bolts
Broken or loose steering gear bolts can cause a loss of steering control, increasing the risk of a crash.
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU ...
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: 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.
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Lengt...
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.
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.
White Cheddar Seasoning packed in the following sizes and configurations: 1. ...
Products were made with recalled California Dairies milk powder due to Salmonella.
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Ma...
CGMP Deviations; deficiencies observed during FDA inspection
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.
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured f...
CGMP Deviations; deficiencies observed during FDA inspection
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit...
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.
ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
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.
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 2...
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.
Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon pla...
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flav...
Defective container:may contain bottles with incomplete seals