Class I - Dangerous
The protective shield was retracted, and the blade was exposed.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
The protective shield was retracted, and the blade was exposed.
Class I - Dangerous
This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
Class I - Dangerous
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Stryker Neurovascular
Class I - Dangerous
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Class I - Dangerous
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Class I - Dangerous
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Class I - Dangerous
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Class I - Dangerous
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Class I - Dangerous
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.
Class I - Dangerous
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Class I - Dangerous
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Class I - Dangerous
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
Centurion Medical Products
Class I - Dangerous
Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
Inadequate seal due to lack of adhesive glue
Class I - Dangerous
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.