March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls CYSTO , Model No SACY80R
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls BORN ON ARRIVAL KIT , Model No LLBN11B
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LABOR & DELIVERY PACK, Model Nos LLLD19H
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls CYSTO PACK , Model N. HKCY31A
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8F
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer,
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., RE
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 26, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Hazard: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
March 19, 2025Medical DevicesFDA
Cordis US Corp recalls Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int
Hazard: Catheter manufactured at the incorrect length.
March 19, 2025Medical DevicesFDA
Zimmer, Inc. recalls Z1 Femoral Hip System, Product Number 611777612
Hazard: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.