Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 79 of 548
FDA Devices Moderate May 8, 2024
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fix…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Cardinal Health 200, LLC
FDA Devices Moderate May 8, 2024
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior t…
IVOCLAR VIVADENT AG
FDA Devices Moderate May 8, 2024
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma,…
Advanced Instruments, LLC
FDA Devices Moderate May 8, 2024
The Oncology Essentials Package of the Spectral CT imaging system.
Philips North America Llc
FDA Devices Moderate May 8, 2024
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and …
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixat…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fix…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on t…
Stryker Neurovascular
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixat…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d.…
SEDECAL SA
FDA Devices Moderate May 8, 2024
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Allergan Sales, LLC
FDA Devices Moderate May 8, 2024
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and f…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic…
Olympus Corporation of the Americas
FDA Devices Moderate May 8, 2024
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Covidien
FDA Devices Moderate May 8, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior …
IVOCLAR VIVADENT AG
FDA Devices Moderate May 8, 2024
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fix…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fix…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixa…
Zimmer, Inc.
FDA Devices Moderate May 8, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Cardinal Health 200, LLC
FDA Devices Moderate May 8, 2024
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate May 8, 2024
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Advanced Research Medical, LLC
FDA Devices Moderate May 8, 2024
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior t…
IVOCLAR VIVADENT AG
FDA Devices Moderate May 8, 2024
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and …
Zimmer, Inc.
CPSC Moderate May 2, 2024
Polaris Recalls Prostar S4 Titan Adventure Snowmobiles Due to Fire Hazard
Polaris Industries Inc., of Medina, Minnesota
FDA Devices Critical May 1, 2024
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
ROUTE 92 MEDICAL INC
FDA Devices Critical May 1, 2024
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculatu…
ROUTE 92 MEDICAL INC
FDA Devices Moderate May 1, 2024
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Baxter Healthcare Corporation
FDA Devices Moderate May 1, 2024
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packa…
Biomet, Inc.
FDA Devices Moderate May 1, 2024
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sol…
Electro Medical Systems SA
FDA Devices Moderate May 1, 2024
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate May 1, 2024
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are s…
Electro Medical Systems SA
FDA Devices Moderate May 1, 2024
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Ion Beam Applications S.A.
FDA Devices Moderate May 1, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
EBI, LLC
FDA Devices Moderate May 1, 2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Zimmer, Inc.
FDA Devices Critical May 1, 2024
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovas…
ROUTE 92 MEDICAL INC
FDA Devices Moderate May 1, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTr…
Covidien LP
FDA Devices Moderate May 1, 2024
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots…
XENEX Disinfection Services Inc.
FDA Devices Moderate May 1, 2024
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Ma…
SEASPINE ORTHOPEDICS CORPORATION