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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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5 recalls that day

3mensio Workstation (Vascular Fenestrated) Software

The 3mensio Workstation software may report user measurements larger than actual anatomical dimensions.

Moderate risk, FDA, Software defect

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

4 recalls that day

Olympus 4K UHD LCD Monitor

The Olympus 4K UHD LCD Monitor can have faulty HDMI and DisplayPort connectors, causing image loss or abnormalities.

Moderate risk, FDA, Device defect

Boston Scientific FARADRIVE Steerable Sheath Clear

Boston Scientific Faradrive Steerable Sheath Clear may have valve damage that can cause air ingress and potential air embolism.

Moderate risk, FDA, Device defect

Halyard Eye Pack Convenience Kit

The Halyard Eye Pack Convenience kit contains an incorrect concentration of Betadine solution.

Moderate risk, FDA, Device defect

SeaSpine Polyaxial Head

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Moderate risk, FDA, Manufacturing problem

5 recalls that day

Ferno-Washington Power F2 Powered Fastening System

The Power F2 Powered Fastening System may experience accelerated roller wear and deformation.

Moderate risk, FDA, Device defect

Hotline Fluid Warming Set

Leakage can occur in specific lots.

Moderate risk, FDA, Device defect

Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod

The P28 Phantom Intramedullary Nail System guide rod has a breach in its sterile barrier.

Moderate risk, FDA, Sterility problem

Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter

The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.

Moderate risk, FDA, Device defect

Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters

Farastar ablation generators and catheters have instructions that do not include catheter information.

Moderate risk, FDA, Labeling error

1 recall that day

Tosoh ST AIA-Pack Testosterone Test

The test's low-quality control results were lower than expected, which could cause falsely elevated or low testosterone results.

Moderate risk, FDA, Device defect

6 recalls that day

Daavlin Photera Phototherapy Devices

Photera 400, Photera 600, and Photera 600 3-D phototherapy devices have incorrect UV sensor gain.

Moderate risk, FDA, Device defect

Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas

Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities that risk sterility breach.

Moderate risk, FDA, Sterility problem

Vasoview Hemopro 2 Endoscopic Vessel Harvesting System

The device was exposed to an out-of-specification sterilization dose during a gamma sterilization run.

Moderate risk, FDA, Quality testing problem

Medtronic DLP and Bio-Medicus Cannulas

Medtronic DLP One-Piece Pediatric Arterial Cannula and Medtronic Bio-Medicus Adult Cannula Kit contain loose foreign material with trace levels of blood.

Moderate risk, FDA, Foreign object

Papablic Replacement Brush Heads

Papablic Replacement Brush Heads can break.

Moderate risk, FDA, Device defect

Rio II Nasal Pillows Interface

The Rio" II Nasal Pillows Interface has a packaging and labeling discrepancy involving product size identification and associated UDI.

Moderate risk, FDA, Labeling error

1 recall that day

Orthofix Minirail External Fixation Devices

Unilateral external fixation devices may be incorrectly labeled.

Moderate risk, FDA, Labeling error

1 recall that day

GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems

Optima XR200amx, XR220amx, and XR240amx systems may have a column safety issue that can cause the arm to drop.

Moderate risk, FDA, Device defect

7 recalls that day

Boston Scientific Rapid Refill Continuous Injection System

The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.

Moderate risk, FDA, Device defect

ICU Medical Plum Duo Infusion and Solo Precision IV Pump

ICU Medical Plum Duo Infusion Pump and Plum Solo Precision IV Pump may deliver up to twice the programmed volume.

Moderate risk, FDA, Device defect

Oscor Abiomed Impella Introducer Kits

Introducer kits for the Impella heart pump may leak from the sidearm, under the sheath cap, and along hub score lines.

High risk, FDA, Manufacturing problem

Argon Medical Devices Cardiovascular and Biopsy Trays

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

High risk, FDA, Sterility problem

Abiomed Impella Heart Pumps and Introducer Kits

The issue is not visually detectable.

High risk, FDA, Manufacturing problem

Olympus Evacuators

Olympus Evacuators may not be consistently sterile when sterilized per instructions.

Moderate risk, FDA, Sterility problem

Intuitive Surgical da Vinci SP Instrument Arm Drape

The da Vinci SP Instrument Arm Drape may detach, exposing a section of instrument arm, which may cause procedure delay or conversion to an alternate approach.

Moderate risk, FDA, Device defect

6 recalls that day

Versius Surgical System

The Versius Surgical System has a potential cybersecurity risk because Secure Boot was not enabled at manufacturing.

Moderate risk, FDA, Software defect

Think Surgical TMINI Femur and Tibia Tracking Arrays

The knob on the TMINI Femur and Tibia Tracking Arrays may loosen, causing potential misalignment.

Moderate risk, FDA, Device defect

Vitek 2 AST-N447 Test Kit

The Vitek 2 AST-N447 test kit may give false resistant results when pouch foil is fractured.

Moderate risk, FDA, Device defect

OmniTract Surgical Retractor System

The OmniTract Surgical Retractor System has a dry time that needs to be extended.

Moderate risk, FDA, Sterility problem

GSP Neonatal GALT Kit

Reduction in the on-board stability of the GSP Galt assay.

Moderate risk, FDA, Device defect

Elekta Brachytherapy Applicators

The tip of the intrauterine tube may detach and remain within a patient.

Moderate risk, FDA, Device defect

7 recalls that day

KL Owen Custom Orthodontic Solution

KL Owen Custom Orthodontic Solution may have a defect causing incorrect bracket placement.

Moderate risk, FDA, Device defect

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

The assay has potential for intermittent well-to-well bias.

Moderate risk, FDA, Device defect

MiniMed 780G Insulin Pump

The insulin pump can stop delivering insulin due to a software anomaly, which may lead to hyperglycemia or diabetic ketoacidosis.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline Convenience Kits contain a temperature probe that has been recalled due to a distribution control error.

Moderate risk, FDA, Device defect

Fresenius Medical Care 5008X Blood Tubing Sets

The 5008X Blood Tubing Set may have connection issues that can cause errors.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Intracept Access Instruments

Intracept Access Instruments may have a sterile barrier breach of the outer tray seal, which could lead to severe infection.

Moderate risk, FDA, Sterility problem

Encore Medical EMPOWR 3D Knee Implants

Due to packaging discrepancy with incorrect product size mixed up.

Moderate risk, FDA, Packaging defect

2 recalls that day

ConvaTec Aquacel Ag Surgical SP

The surgical dressing was manufactured out of specification.

Moderate risk, FDA, Quality testing problem

Olympus Single Use Distal Cover

The Olympus Single Use Distal Cover has a newly designed version to replace the previous design.

Moderate risk, FDA, Device defect

9 recalls that day

Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses

Sterile tourniquet hoses may have a sterility breach in the sealing area, potentially causing moderate localized infection.

Moderate risk, FDA, Sterility problem

GORE TAG Thoracic Branch Endoprosthesis Side Branch Component

The Gore TAG Thoracic Branch Endoprosthesis Side Branch Component can separate due to catheter separation.

Moderate risk, FDA, Device defect

Medline Reprocessed Electrophysiology and Ultrasound Catheters

Reprocessed electrophysiology catheters may contain small particles of residual material, posing a risk of inflammatory response or systemic infection.

High risk, FDA, Foreign object

Bard Access Systems Catheters, Dialysis Catheters, and Biopsy Trays

Bard Access Systems Catheters, Dialysis Catheters, and Biopsy Trays contain lidocaine ampoules that were manufactured under deficient manufacturing practices.

Moderate risk, FDA, Manufacturing problem

BD Medline 111 Gravity Set

The gravity set labeled "Not for Human Use" was shipped to the U.S. market.

Moderate risk, FDA, Unapproved product

Medtronic Harmony Delivery Catheter System

The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.

High risk, FDA, Manufacturing problem

Solar GI System (Water Perfusion)

The Solar GI System can accumulate moisture inside its tubing, affecting airflow or pressure measurement.

Moderate risk, FDA, Device defect

Covidien Shiley Disposable Decannulation Plug

The product labeling incorrectly includes a symbol indicating non-DEHP, but the product includes 30 to 35% DEHP.

Moderate risk, FDA, Labeling error