Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IICYSTO , Model No SACY80R
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIURO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IICENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIC-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIBORN ON ARRIVAL KIT , Model No LLBN11B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIGENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIOPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILABOR & DELIVERY PACK, Model Nos LLLD19H
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIC-SECTION PACK, Model Nos LLCS44F LLCS44F-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IICYSTO PACK , Model N. HKCY31A
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIMAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIHIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIDR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths 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
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-26FDA-DeviceSmiths Medical ASD, Inc.Class Ismiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-19FDA-DeviceCordis US CorpClass IIVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Catheter manufactured at the incorrect length.
- 2025-03-19FDA-DeviceZimmer, Inc.Class IIZ1 Femoral Hip System, Product Number 611777612
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
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