F & A Foundation Reign Medical Clench Staple System (Compression)
The Reign Medical Clench Staple System has not had its performance characteristics adequately established.
Device defect recalls
Recalls flagged for device defect, newest first. 384 recalls
3 recalls
8 recalls
Captus 4000e Thyroid Uptake System
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Abiomed Impella Controllers
The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.
3 products
Datex-Ohmeda Aisys Anesthesia Systems
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.
4 products
Stryker Sustainability Solutions Ethicon XCEL Bladeless Trocars
Reusable access port system may crack or seperate during use.
6 products
Boston Scientific StoneSmart Connect Console
The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.
Howmedica Osteonics Orthopaedic Implant Components
Orthopaedic implant components made from aged Uhmwpe may oxidize, causing wear and potential harm.
12 products
restor3d Kinos Axiom Total Ankle System with Axiom PSR, Flat-Cut (Cut Guide)
The Kinos Axiom Total Ankle System was packaged with incorrect cutting guides, which may cause delayed surgery, poor alignment, or need for revision.
Hemospray Endoscopic Hemostat
The hemostatic device has an issue with endoscope adherence and inability to spray powder.
6 recalls
Straumann GM Helix Implant
The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.
SunMed Tracheal Tube
The tracheal tube has a suction catheter that may not pass through smoothly.
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.
6 productsNOxBOXi Nitric Oxide Delivery System
The NOxBOXi Nitric Oxide Delivery System has potential oxygen tubing leaks that may cause oxygen desaturation.
Happiest Baby SNOO Sleep Sacks
Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.
2 products
BD Alaris Pump Infusion Sets
BD Alaris Pump Infusion Sets have performance data discrepancies that may lead to inappropriate pump performance.
5 recalls
Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit
The syringe kit may not be properly sterilized due to a manufacturing issue.
Carescape Central Station
Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of events.
Bravo CF Capsule Delivery Device
Capsule may fail to attach to the esophagus or detach from the delivery device.
Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter
Reason given by FDA: this is a downstream recall of class I recall RES 98777.
2 products
ICU Medical IV and Oncology Administration Sets
Intravascular administration tubing sets may have black specks in drip chambers.
10 products
1 recall
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.
2 recalls
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.
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.
1 recall
Fresenius Medical Care Acid Concentrates
GRANUFLO Dry Acid Concentrate, NaturaLyte, and Citrasate have complaints of blue-green discoloration.
3 products
1 recall
Fresenius Medical Care 5008X Blood Tubing Sets
Blood tubing sets may leak at the connection, causing blood loss and hypovolemia.
4 products
1 recall
Philips Brilliance, IQon Spectral and Ingenuity CT Scanners
Philips CT systems have an unintended radiation issue that could affect equipment performance.
4 products1 recall
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.
1 recall
STA Staclot Protein S
STA Staclot Protein S has a positive drift in QC values within its stated 4-hour onboard stability period.
4 recalls
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.
2 products
Healthmark ProChek Protein Tests
The ProChek tests were made with an expired ingredient, which may cause false results.
2 products
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver
The suture anchor may contain an incorrect patient implant card, affecting device identification and traceability.
Fresenius Medical Care 2008T BlueStar Hemodialysis Machine
The 2008T BlueStar Hemodialysis Machine has received complaints about flow-, no water-, or temperature-related alarms.
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.
2 products
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.
2 products
Canon Alphenix Angiography Systems
Alphenix X-ray systems may have loose fixing screws in the ceiling movement gear.
1 recall
Philips Incisive CT with Software V4.5&V5.0
Philips Incisive CT may fail to trigger a clinical scan during Bolus Tracking.
1 recall
Boston Scientific ENROUTE Transcarotid Neuroprotection System
The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.
2 products
3 recalls
Esteem Body Soft Convex Urostomy Pouch
Esteem Body Soft Convex Urostomy Pouch may leak from cap during use.
BMC Luna G3 APAP Machines
The firmware defects could result in unintended serious adverse health consequences.
Veritas Standard Glenoid Baseplate
The Veritas Standard Glenoid Baseplate has incorrect machining of a screw hole, potentially causing improper screw engagement.
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.
3 products
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.
1 recall
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.
2 products
13 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.
2 products
Paragon 28 Navicular Cage Foot Implants
The foot implant has elevated oxygen levels that may reduce material ductility.
2 products
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.
3 products
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.
2 products
AVID Medical Halyard LAVH Packs
The Halyard Lavh Pack with Clearify Visualization System may leak because the component was sterilized against manufacturer recommendation.
Getinge Y Sensor Module, Servo-U, Servo-N
The module did not undergo electrical safety tests and functional tests during production.
Boston Scientific OverStitch Suture Cinch and Suture Cinch Long
The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.
2 products