Avanos Medical MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall — FDA Z-2347-2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Complete FDA and NHTSA recall records dated in June 2026.
These records include useful source details for the selected month.
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.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.