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Medical device recalls

Medical device recalls from FDA, newest first.
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7 recalls

NOxBOXi Nitric Oxide Delivery System

The NOxBOXi Nitric Oxide Delivery System has potential oxygen tubing leaks that may cause oxygen desaturation.

Moderate risk, FDA, Device defect

Happiest Baby SNOO Sleep Sacks

Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.

Moderate risk, FDA, Device defect

BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets have performance data discrepancies that may lead to inappropriate pump performance.

High risk, FDA, Device defect

3 recalls

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit contains applicators contaminated with Aspergillus penicillioides.

High risk, FDA, Contamination

Medline Convenience Kits

Medline Convenience Kits contain sterile applicators that may have fungal contamination, potentially causing serious infections.

High risk, FDA, Contamination

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument has a software issue.

Moderate risk, FDA, Software defect

9 recalls

Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit

The syringe kit may not be properly sterilized due to a manufacturing issue.

Moderate risk, FDA, Device defect

Maquet Percutaneous Insertion Kits and Guidewires

The packaging may not consistently maintain sterile barrier integrity.

Moderate risk, FDA, Sterility problem

Carescape Central Station

Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of events.

Moderate risk, FDA, Device defect

Bravo CF Capsule Delivery Device

Capsule may fail to attach to the esophagus or detach from the delivery device.

High risk, FDA, Device defect

Medline Open Heart A Pack Convenience Kit

The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX and Philips PIC iX Essentials

Philips Patient Information Center iX may freeze and become unresponsive due to software malfunction.

Moderate risk, FDA, Software defect

StatStrip Glucose Meters

A software issue can cause the device to retain a previously scanned barcode, so a new patient's glucose result may be assigned to the previous patient's record.

High risk, FDA, Software defect

Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter

Bard Access Systems is recalling its Power-Trialysis Short-Term Straight Dialysis Catheter because this is a downstream recall of class I recall RES 98777.

High risk, FDA, Device defect

ICU Medical IV and Oncology Administration Sets

Intravascular administration tubing sets may have black specks in drip chambers.

Moderate risk, FDA, Foreign object

2 recalls

Windstone Medical Packaging AMS Convenience Kit DSAEK Pack

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

Moderate risk, FDA, Device defect

MedicaLyte and Citric Complete Concentrates

Hemodialysis concentrates contain high endotoxin levels.

Moderate risk, FDA, Contamination

1 recall

Medical Action Industries Epidural Kits

Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

High risk, FDA, Sterility problem

5 recalls

Getinge PVC Thoracic Catheter

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Moderate risk, FDA, Quality testing problem

Lutronic DermaV Laser System

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Moderate risk, FDA, Device defect

HeartSine Samaritan PAD Defibrillators SAM 350P, SAM 360P and SAM 450P

HeartSine SAM 350P, SAM 360P, and SAM 450P defibrillators have a damaged membrane tail causing an intermittent fault.

Moderate risk, FDA, Device defect

AVID Medical Halyard IV Start Kits

The Halyard IV Start Kit lacks sterility assurance due to wrinkles in the paper lidding that may breach the seal area.

Moderate risk, FDA, Sterility problem

Bard Foley Catheter Trays and Intermittent Catheter Trays

Products that contain the Pericare Wipes may be contaminated on the surface.

Moderate risk, FDA, Contamination

2 recalls

Cardinal Health 200 Presource Packs Containing CliniClean Pericare Wipes Within BD Urinary Catheter Trays

The wipes in these catheter trays may be contaminated with a lubricant, causing skin irritation.

Moderate risk, FDA, Contamination

Fresenius Medical Care Acid Concentrates

GRANUFLO Dry Acid Concentrate, NaturaLyte, and Citrasate have complaints of blue-green discoloration.

Moderate risk, FDA, Device defect

4 recalls

Fresenius Medical Care 5008X Blood Tubing Sets

Blood tubing sets may leak at the connection, causing blood loss and hypovolemia.

Moderate risk, FDA, Device defect

B Braun Medical Discofix Four Way Stopcock Extension Sets

The Discofix Four WAY Stopcock has an incorrect expiration date printed on the carton shipper label.

Moderate risk, FDA, Labeling error

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System

The Insertable Cardiac Monitor System may delay AF Burden Alert notifications, potentially delaying clinical evaluation.

Moderate risk, FDA, Software defect

Medos International Velys Enabling Tech Robotic-Assist Station

The Velys Enabling Tech Robotic-Assist Station has a software issue that may cause unintended movement of the robotic arm.

Moderate risk, FDA, Software defect

1 recall

Philips Brilliance, IQon Spectral and Ingenuity CT Scanners

Philips CT systems have an unintended radiation issue that could affect equipment performance.

Moderate risk, FDA, Device defect

4 recalls

Medline Convenience Kits with BD ChloraPrep Applicators

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators may have an open or incomplete seal, leading to infection.

Moderate risk, FDA, Contamination

Baxter Novum IQ Syringe Pump

The syringe pump has a software issue that may occur during multi-syringe infusion.

Moderate risk, FDA, Software defect

Johnson & Johnson HEALON EndoCoat PRO and HEALON DUET PRO II

Viscoelastic products used in cataract procedures may cause corneal abrasion, iris trauma, or descemet's membrane detachment if forced.

Moderate risk, FDA, Device defect

Medline Convenience Kits

Medline Convenience Kits contain applicators with a potential breach of sterility in the packaging.

Moderate risk, FDA, Sterility problem

2 recalls

STA Staclot Protein S

STA Staclot Protein S has a positive drift in QC values within its stated 4-hour onboard stability period.

Moderate risk, FDA, Device defect

Halyard Medical Convenience Kits

Halyard medical convenience kits may contain neurological sponges with unexpected variability of endotoxin levels.

Moderate risk, FDA, Sterility problem

1 recall

GE Portrait Core Services Software

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer.

Moderate risk, FDA, Software defect

8 recalls

ICU Medical IV Sets with Drip Chambers

IV Sets with drip chambers may have black specks which could result in a delay in therapy.

Moderate risk, FDA, Device defect

Olympus POWERSEAL Curved Jaw Sealer & Divider

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Moderate risk, FDA, Labeling error

IMRIS Operating Room Tables ORT200 and ORT300

The ORT200 operating room table may have a mechanical failure that prevents locking, posing a risk of injury.

Moderate risk, FDA, Device defect

Healthmark ProChek Protein Tests

The ProChek tests were made with an expired ingredient, which may cause false results.

Moderate risk, FDA, Device defect

FUJIFILM Synapse PACS Software

The software may cause the ruler measurement to be inaccurate.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline convenience kits contain a potentially contaminated component.

Moderate risk, FDA, Contamination

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver

The suture anchor may contain an incorrect patient implant card, affecting device identification and traceability.

Moderate risk, FDA, Device defect

Fresenius Medical Care 2008T BlueStar Hemodialysis Machine

The 2008T BlueStar Hemodialysis Machine has received complaints about flow-, no water-, or temperature-related alarms.

Moderate risk, FDA, Device defect

3 recalls

Henry Schein Structur 2 SC and Grandio Restorative Materials

Structur 2 SC Temporary Resin Cartridge Refill was distributed with incorrect packaging and instructions.

Moderate risk, FDA, Device defect

Midmark Digital ECG HD+12 and IQecg Digital ECG

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Moderate risk, FDA, Device defect

Canon Alphenix Angiography Systems

Alphenix X-ray systems may have loose fixing screws in the ceiling movement gear.

Moderate risk, FDA, Device defect

7 recalls

Halyard Total Joint and DaVinci TruCustom Bundles

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Moderate risk, FDA, Labeling error

Merge PACS and Merge OrthoPACS, Medical Imaging Diagnostic Workstation

The medical imaging diagnostic workstation may display measurements inaccurately due to a software issue.

Moderate risk, FDA, Software defect