Skip to main content

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).
Filters · 1Sort Newest
Agency
Risk level
Status
Date
Sold in

5 recalls that day

Lutronic DermaV Laser System

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

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

Halyard IV Start Kits

Halyard IV Start Kit Non-Sterile 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 have contamination on the surface.

Moderate risk, FDA, Contamination

2 recalls that day

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

Presource Packs with CliniClean Pericare Wipes in BD Urinary Catheter Trays may be contaminated with a lubricant, causing skin irritation.

Moderate risk, FDA, Contamination

Fresenius Medical Care Acid Concentrates

Fresenius Medical Care Renal Therapies Group is recalling its Granuflo Dry Acid Concentrate because of complaints of blue-green discoloration in product.

Moderate risk, FDA, Device defect

4 recalls that day

Fresenius Medical Care 5008X Blood Tubing Sets

Blood tubing sets may leak at the connection between the Arterial Alpha Clip and the main line, 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 LUX-Dx Insertable Cardiac Monitor System may delay AF Burden Alert notification, potentially delaying clinical evaluation or therapeutic intervention.

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 that day

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 that day

Medline Convenience Kits with BD ChloraPrep Applicators

Medline Convenience Kits containing BD ChloraPrep Clear Applicators may have an open or incomplete seal, which could lead 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, exposing patients and users to microbial contamination.

Moderate risk, FDA, Sterility problem, FDA event number 99334

2 recalls that day

STA Staclot Protein S

STA Staclot Protein S may show 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 that day

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 that day

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

The outer shelf box is incorrectly labeled as a 37-cm device.

Moderate risk, FDA, Labeling error

IMRIS Operating Room Tables ORT200 and ORT300

The operating room table may fail to lock, posing a risk of injury to the patient.

Moderate risk, FDA, Device defect

Healthmark ProChek Protein Tests

Healthmark ProChek-II and ProChek-W protein 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, FDA event number 99507

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver

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

Moderate risk, FDA, Device defect

Fresenius Medical Care 2008T BlueStar Hemodialysis Machine

Complaints were received about flow, no water and temperature alarms on 2008T BlueStar Hemodialysis machines.

Moderate risk, FDA, Device defect

3 recalls that day

Henry Schein Structur 2 SC and Grandio Restorative Materials

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Moderate risk, FDA, Device defect

Midmark Digital ECG HD+12 and IQecg Digital ECG

A communication problem may cause incorrect electrocardiogram waveforms and an inaccurate beats-per-minute calculation.

Moderate risk, FDA, Device defect

Canon Alphenix Angiography Systems

The Alphenix X-ray system has ceiling movement gear screws that may become loose.

Moderate risk, FDA, Device defect

7 recalls that day

Halyard Total Joint and DaVinci TruCustom Bundles

Halyard Total Joint and DaVinci TruCustom Bundles have labeling Deficiency.

Moderate risk, FDA, Labeling error

Merge PACS and Merge OrthoPACS, Medical Imaging Diagnostic Workstation

Merge PACS and Merge OrthoPACS, a medical imaging diagnostic workstation, may display measurements inaccurately.

Moderate risk, FDA, Software defect

American Contract System Convenience Kits

The convenience kits contain catheters that may not meet performance specifications.

Moderate risk, FDA, Quality testing problem

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

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

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

The kits contain neurosponges with potential out-of-specification levels of endotoxin.

Moderate risk, FDA, Quality testing problem

2 recalls that day

American Contract Systems Medical Procedure Kits and Trays

Medical procedure kits and trays contain neurological sponges with potentially variable endotoxin levels.

Moderate risk, FDA, Sterility problem

Boston Scientific ENROUTE Transcarotid Neuroprotection System

Potential for arterial sheath tip separation or partial tip separation during use.

High risk, FDA, Device defect

3 recalls that day

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

Luna G3 Apap can shut down and display an error under extreme conditions due to a firmware defect.

High risk, FDA, Device defect

Veritas Standard Glenoid Baseplate

The Veritas Standard Glenoid Baseplate has incorrectly machined peripheral screw holes, potentially causing improper screw engagement.

Moderate risk, FDA, Device defect

2 recalls that day

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

Loaner insulin pumps may have been cleaned with incompatible products, damaging the case or keypad and causing insulin delivery issues.

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 that day

Siemens Healthcare Diagnostics Beckman Coulter and Syva EMIT 2000 Quinidine Assay

The assay may exhibit unacceptable precision performance, leading to erroneously elevated quinidine measurements.

Moderate risk, FDA, Device defect

Beckman Coulter DxC 500I Clinical Analyzer Modules

A software defect in the Parameter Package import logic overwrites predefined calculated test rules.

Moderate risk, FDA, Software defect

16 recalls that day

Spectral Instruments Lago X and Ami HTX Imaging Systems

Spectral Instruments is recalling its Lago X and Ami HTX because of Momentary absence of On-Screen "X-Ray On" banner during run 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

Overheating on 115V CPU boards may cause the device to shut down.

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 report low reactive results as nonreactive.

Moderate risk, FDA, Device defect