Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannu...
The cannulation of the CCS screw is not centered.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-1...
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUL...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog N...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, ...
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; ...
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUL...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Halyard, Drape Pack. Kit Code: LMDP36-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
Allia IGS 5 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27,...
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Bicarby Dialysate; Model number: RFP-400-G;
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Plum Duo Infusion Pump, 40002-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: ...
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.