nhtsa regulated Recalls

Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025

Limited system movements after startup .

Applied Medical Technology Recalls NutraGlide ENFit Nasal Feeding Tube 5F-6F x 55 in (1,780 units)

Applied Medical Technology recalled 1,780 NutraGlide ENFit nasal feeding tubes distributed in Massachusetts and Rhode Island. Distal tips on these devices may detach at lower than expected forces. Stop using immediately and follow the recall instructions.

Applied Medical Technology NutraGlide ENFit Nasal Feeding Tubes Recalled for 390 Units in 2025

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Applied Medical Technology NutraGlide ENFit Nasal Feeding Tube Recall 840 Units (2025)

The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

Lannett Lisdexamfetamine Recall Alerts 40 mg Capsules for Label Mix-Up (2025)

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Quallent Pharmaceuticals Health LLC Recall Expands for Duloxetine Delayed-Release Capsules Over Imp-

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Schiller Argus PB-3000 Vital Signs Monitor Recall Affects 266 US Units

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

Glenmark Carvedilol Tablets Recalled Over Nitrosamine Impurity

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Glenmark Carvedilol 3.125 mg Recall for Nitrosamine Impurity Affects 44,328 Bottles (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Westminster Pharmaceuticals Metoprolol Tartrate 50 mg Recall Over Nitrosamine Above ADI Level (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Glenmark Carvedilol 12.5 mg Tablets Recalled for NNCI Impurity Exceeding FDA Limit (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Glenmark Carvedilol 25 mg Recall Expands Over NNCI Impurity Above FDA Limit in 14,976 Bottles

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Sandoz/Cardinal Health Enoxaparin Sodium Injection Recall Over Mispacked Bags

Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.

B. Braun Medical Lactated Ringers Injection Recall for Sterility Concerns Affecting 74,088 Units (US

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

AVID Medical CPT BASIC IR PACK 1646381 Recall for Sterility Risk (2025)

AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.

Medline Recalled 7,913 Reprocessed ACUSON AcuNav Ultrasound Catheters for Intracardiac Imaging

Fortress Introducer Sheath System 386594 Recall Expanded; 2,500 Units Worldwide Distribution (High-R

Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

Exela Pharma Sciences 4.2% Sodium Bicarbonate Injection Recalled Over Arsenic Impurity Out-Of-Spec

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Over 4,300 S.I.N. Implant EPIKUT Dental Implants Recalled Due to Quality Concerns

Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.