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Medical device recalls

Medical device recalls from FDA, newest first.
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9 recalls

Hemospray Endoscopic Hemostat

The hemostatic device has an issue with endoscope adherence and inability to spray powder.

Moderate risk, FDA, Device defect

Embecta Nano Pro Un-Cannulated Demo Samples

Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Moderate risk, FDA, Labeling error

4 recalls

Straumann GM Helix Implant

The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.

Moderate risk, FDA, Device defect

GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software

Centricity Enterprise Archive software may associate historical imaging data with the wrong patient, potentially causing misdiagnosis or delayed care.

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

2 recalls

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

8 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

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

4 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

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

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

6 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

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

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

4 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

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

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

1 recall

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

2 recalls

Esteem Body Soft Convex Urostomy Pouch

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

Moderate 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

1 recall

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

11 recalls

Paragon 28 Navicular Cage Foot Implants

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

Low risk, FDA, Device defect