Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm recall — FDA Z-2403-2026
Reusable electrodes may not meet expected performance levels.
Complete FDA and NHTSA recall records dated in 2026, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Reusable electrodes may not meet expected performance levels.
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Due to incorrect incubation process being performed on product.
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…
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
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…
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…
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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…
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an…
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or…
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Reusable electrodes may not meet expected performance levels.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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…
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…
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Particulate matter: Particulate matter identified as glass.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.