Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US
Class I - Dangerous
Potential breach of sterile barrier packaging.
Class I - Dangerous
Potential breach of sterile barrier packaging.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Healthmark Industries Co.
Class I - Dangerous
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Mozarc Medical US
Class I - Dangerous
Potential breach of sterile barrier packaging.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical
Class I - Dangerous
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
Becton Dickinson Infusion Therapy Systems
Class I - Dangerous
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
Class I - Dangerous
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.