Medical device recalls
38983 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 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.
- 2025-03-19FDA-DeviceStryker CorporationClass IIStryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief