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Medical device recalls

Medical device recalls from FDA, newest first.
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7 recalls

American Contract System Convenience Kits

American Contract System Convenience Kits did not meet applicable performance specifications.

Moderate risk, FDA, Quality testing problem

Philips Incisive CT with Software V4.5&V5.0

Philips Incisive CT may fail to trigger a clinical scan during Bolus Tracking.

Moderate risk, FDA, Device defect

Medline Trach Tube Kit

The Medline medical convenience kit labeled as Trach Tube Kit has a component labeling discrepancy.

Moderate risk, FDA, Labeling error

Hollister Onli Hydrophilic Urethral Intermittent Catheters

The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.

Moderate risk, FDA, Manufacturing problem

Medline Medical Convenience Kits

Medline medical convenience kits contain neurosponges with potential out-of-specification endotoxin levels.

Moderate risk, FDA, Quality testing problem

2 recalls

American Contract Systems Medical Procedure Kits and Trays

Medical procedure kits and trays may have unexpected variability of endotoxin levels on included sponges.

Moderate risk, FDA, Sterility problem

Boston Scientific ENROUTE Transcarotid Neuroprotection System

The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.

High risk, FDA, Device defect

3 recalls

Esteem Body Soft Convex Urostomy Pouch

Esteem Body Soft Convex Urostomy Pouch may leak from cap during use.

Moderate risk, FDA, Device defect

BMC Luna G3 APAP Machines

The firmware defects could result in unintended serious adverse health consequences.

High risk, FDA, Device defect

Veritas Standard Glenoid Baseplate

The Veritas Standard Glenoid Baseplate has incorrect machining of a screw hole, potentially causing improper screw engagement.

Moderate risk, FDA, Device defect

2 recalls

MiniMed 640G, 670G, and 780G Insulin Pump

Loaner insulin pumps may have been cleaned with chemically incompatible products, damaging the case or keypad and allowing moisture ingress.

Moderate risk, FDA, Device defect

Fort Defiance Industries Automated Field Steam Sterilizer

The Automated Field Steam Sterilizer may have an intermittent loss of ground continuity in its water recovery system connector.

Moderate risk, FDA, Device defect

2 recalls

Siemens Healthcare Diagnostics Beckman Coulter and Syva EMIT 2000 Quinidine Assay

The Syva EMIT 2000 Quinidine Assay has unacceptable precision, leading to erroneously elevated quinidine measurements.

Moderate risk, FDA, Device defect

Beckman Coulter DxC 500I Clinical Analyzer Modules

Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.

Moderate risk, FDA, Software defect

16 recalls

Spectral Instruments Lago X and Ami HTX Imaging Systems

Lago X has a momentary absence of the on-screen X-Ray On banner during a readiness check.

Moderate risk, FDA, Device defect

Paragon 28 Navicular Cage Foot Implants

The foot implant has elevated oxygen levels that may reduce material ductility.

Low risk, FDA, Device defect

Blanketrol II, Blanketrol III, and Innercool Coolblue Console

The Blanketrol II thermal regulating system may shut down due to overheating of its 115V CPU board.

Moderate risk, FDA, Device defect

Paragonix Technologies KidneyVault Portable Renal Perfusion System

The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Moderate risk, FDA, Software defect

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen

The Syphilis Screen assay may have a negative patient bias, causing low reactive results to be reported as nonreactive.

Moderate risk, FDA, Device defect

AVID Medical Halyard LAVH Packs

The Halyard Lavh Pack with Clearify Visualization System may leak because the component was sterilized against manufacturer recommendation.

Moderate risk, FDA, Device defect

Getinge Y Sensor Module, Servo-U, Servo-N

The module did not undergo electrical safety tests and functional tests during production.

Moderate risk, FDA, Device defect

Boston Scientific OverStitch Suture Cinch and Suture Cinch Long

The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.

Moderate risk, FDA, Device defect

Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device

The TD Navio Midi Speech Generating Device may have damaged battery mounting tabs, causing internal short circuit and heating.

Moderate risk, FDA, Device defect

Arrowhead DE Arrow-LOK Implant

The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.

Moderate risk, FDA, Sterility problem

Kico Knee Innovation Arvis Surgical Navigation System GEN 2

The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.

Moderate risk, FDA, Device defect

Philips Cardiac Workstation 5000 and 7000

The Cardiac Workstation 5000 may provide inaccurate heart rate data.

Moderate risk, FDA, Device defect

Dentsply Sirona Capsule Mixer

The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.

Moderate risk, FDA, Device defect

Intersurgical Guedel Oropharyngeal Airways

One-Piece Guedel Airway devices could potentially be occluded or partially occluded.

Moderate risk, FDA, Device defect

Foundation Medicine Hamilton Microlab STAR Liquid Handler

The Hamilton Microlab STAR Liquid Handler has a software issue that can cause spontaneous software closures.

Moderate risk, FDA, Software defect

EndoFLIP System

The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.

Moderate risk, FDA, Device defect

2 recalls

Cardinal Health Presource Kits

Procedure kits contain neurological sponges with unexpected variability in endotoxin levels.

Moderate risk, FDA, Contamination

BD Intravascular Administration and Extension Sets

Intravascular administration sets may not have received adequate sterilization processing.

Moderate risk, FDA, Sterility problem

3 recalls

Erbe USA ERBECRYO 2 Cryosurgical Unit

The ERBECRYO 2 Cryosurgical Unit can rupture its cryoprobe due to excessive pressure from a strong pull on the hose.

Moderate risk, FDA, Device defect

ProNephro AKI (NGAL) Reagent Kit

The ProNephro AKI (NGAL) Reagent Kit may lead to missed diagnosis of renal disease.

Moderate risk, FDA, Device defect

BIOFIRE Respiratory Panel 2.1 (RP2.1)

BioFire Diagnostics is recalling its Biofire Respiratory Panel 2.1 because of increase in false negative results.

Moderate risk, FDA, Device defect

4 recalls

Straumann Bone Level Tapered (BLT) Implant

The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.

Moderate risk, FDA, Labeling error

Waldemar Link Endo-Model Tibial Plateau Replacement Sets

The Endo-Model replacement set for a tibial plateau incorrectly contains a Pure Hinge plateau, which could lead to prolonged surgery or implant wear.

Moderate risk, FDA, Device defect

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter

The Baxter Duo-Vent Solution Set and Male Luer Lock Adapter can have air bubbles in the drip chamber and tubing.

High risk, FDA, Device defect

Spectra Medical Devices Sodium Chloride Injection

Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.

High risk, FDA, Sterility problem

6 recalls

OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source

The ER-Spec vaginal speculum may have a burr on the blade, introducing a sharp edge for patients and providers.

Moderate risk, FDA, Device defect

Philips Azurion

Philips Azurion x-ray system has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, Software defect

Philips Azurion Interventional Fluoroscopic X-Ray Systems

Philips Azurion Rystem has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, Software defect

Straumann GM Helix Dental Implants

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.

Moderate risk, FDA, Labeling error

Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems

Allura Xper FD has a firmware issue that could lead to loss of geometry movements.

Moderate risk, FDA, Software defect

Terumo Glidesheath Slender A-Kit

The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Moderate risk, FDA, Device defect

8 recalls

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests

Neisseria meningitidis Gp C 2ml/VL is not performing to IFU criteria, not positive to ATCC13102 within 60 seconds.

Moderate risk, FDA, Quality testing problem

Medline Micro-Kill Bleach Germicidal Bleach Wipes

Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration before the end of their shelf life.

Moderate risk, FDA, Contamination

Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices

V-Loc 90 Absorbable Wound Closure Device may have a perforation or tear in its sterile barrier packaging, which may lead to infection or prolonged surgery.

Moderate risk, FDA, Sterility problem

Galt Medical Boston Scientific Enhance Transcarotid/Peripheral Access Kit

The Enhance Transcarotid/Peripheral Access Kit has black depth markings that may detach from the outer sheath.

Moderate risk, FDA, Device defect

Xhibit Central Station

The Xhibit Central Station has audio/video failures due to a display port component.

Moderate risk, FDA, Device defect