Open, ClassifiedPosted Mar 19, 2025·Initiated Feb 17, 2025
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Reason: Increased risk for valve housing detachment causing leakage.
Root cause: Process control
Recalling firm: B Braun Medical IncType: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.Recall #Z-1397-2025 Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1277-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1278-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1279-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1280-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1281-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1282-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1283-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1284-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1285-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1286-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1287-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 13, 2025
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Port & Catheter, Implanted, Subcutaneous, IntravascularDistribution: Worldwide distribution.Recall #Z-1288-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 10, 2025
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL
REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Reason: Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Root cause: Process change control
Recalling firm: Immuno-Mycologics, IncType: Antigen, Cf And / Or Id, Coccidioides ImmitisDistribution: Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.Recall #Z-1389-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 4, 2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason: Product is mislabeled with the incorrect fill volume.
Root cause: Process control
Recalling firm: Angiodynamics, Inc.Type: Prostate Immobilizer Rectal BalloonDistribution: US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Recall #Z-1391-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 10, 2025
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Root cause: Software design
Recalling firm: Brainlab AGType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution.Recall #Z-1392-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 11, 2025
Medline procedure kits labeled as:
1) C SECTION, Pack Number DYNJ909098
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cesarean Section TrayDistribution: Worldwide - US Nationwide and the country of Canada.Recall #Z-1393-2025
Open, ClassifiedPosted Mar 18, 2025·Initiated Feb 11, 2025
Medline procedure kits labeled as:
1) EYE PACK, Pack Number VAL038BSCLC
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Eye TrayDistribution: Worldwide - US Nationwide and the country of Canada.Recall #Z-1394-2025
Open, ClassifiedPosted Mar 17, 2025·Initiated Feb 14, 2025
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Reason: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Root cause: Labeling Change Control
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.Recall #Z-1372-2025
Open, ClassifiedPosted Mar 17, 2025·Initiated Feb 14, 2025
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Reason: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Root cause: Labeling Change Control
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.Recall #Z-1373-2025