Medical Device Shortages

Current shortages reported by the FDA

Current medical device shortages

Medical device shortages can pose serious challenges for hospitals, healthcare providers, and patients who rely on these products for essential care. To promote transparency, the FDA maintains a publicly available Medical Device Shortage List under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The list identifies categories of devices the FDA has determined to be in shortage, along with devices that manufacturers have permanently discontinued. While a device type may appear on the list, this does not necessarily mean that patient care has been impacted—only that the FDA is monitoring availability concerns.

The Office of Supply Chain Resilience (OSCR) within the FDA’s Center for Devices and Radiological Health (CDRH) oversees efforts to anticipate and mitigate supply chain disruptions. This includes managing the shortage list and coordinating with manufacturers and stakeholders to help prevent or resolve shortages.

Category Product Code (Description) Availability and Estimated Shortage Duration Additional Information Reason for Interruption (per 506J) Date (YYYY/MM/DD)
Cardiovascular – Circulatory Support, Structural and Vascular Devices DSQ (Ventricular (assist) bypass) Estimated through Q4 2025 Pediatric ventricular assist devices are in shortage. Shortage or discontinuance of a component, part or accessory of the device. 2025/07/16
Initial
Cardiovascular – Circulatory Support, Structural and Vascular Devices BYS (Oxygenator, Long Term Support Greater Than 6 Hours) Estimated through Q4 2025. Oxygenator devices intended for extracorporeal circulation are in shortage. Shortage or discontinuance of a component, part or accessory of the device.

2023/09/11 Initial

2025/07/16 Reverified

Cardiovascular – Circulatory Support, Structural and Vascular Devices DTZ (Oxygenator, Cardiopulmonary Bypass) Estimated through Q4 2025. Oxygenator devices intended for extracorporeal circulation are in shortage. Shortage or discontinuance of a component, part or accessory of the device.

2023/09/11 Initial

2025/07/16 Reverified

Gastroenterology/Urology – Renal, Gastrointestinal, Obesity and Transplant Devices FJK (Set, Tubing, Blood, With and Without Anti-Regurgitation) Estimated through Q3 2025 Bloodlines used in dialysis are in shortage. The FDA is providing a Letter to Health Care Providers. Shortage or discontinuance of a component, part or accessory of the device. 2025/03/14 Initial
General & Plastic Surgery – Surgical and Infection Control Devices GEI (Electrosurgical, Cutting & Coagulation & Accessories) Estimated through Q4 2025 To provide recommendations to health care providers and facilities that use endoscopic vessel harvesting devices, the FDA is providing a Letter to Health Care Providers Shortage or discontinuance of a component, part, or accessory of the device.

2024/11/15 Initial

2025/07/16 Reverified