Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYN...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS76...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y ...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 ...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 F...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
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.
Allia IGS 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.
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.
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.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUS...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit ...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Prod...
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL...
Reusable electrodes may not meet expected performance levels.
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 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: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm 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 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, 52 TESTS Product Name: SPO...
Due to incorrect incubation process being performed on product.
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, Drape Pack. Kit Code: LMDP36-01.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0....
Reusable electrodes may not meet expected performance levels.
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.