ARCHIVED 2. List of Medical Devices - Notification of Shortages [2021-10-22]

Notice to the reader:

This is an archived list. Please refer to the most current version of this list.

Manufacturers and importers must report shortages of medical devices (or their components, accessories, or parts) that are on the following list by completing the electronic reporting form.

Supersedes: 2021-05-20
Date issued: 2021-07-05

Access archived versions of this list.

Category / Name of the Device

Class I Medical Devices

• Masks (surgical, procedure or medical masks) - Level 1, 2, 3 (ATSM)
• N95 respirators for medical use
• KN95 respirators for medical use
• Face shields
• Gowns (isolation or surgical gowns) - Level 2, 3 and 4
• Gowns (chemotherapy gowns)

Class II Medical Devices

• Ventilators (including bi-level positive airway pressure or BiPAP machines, and continuous positive airway pressure or CPAP machines)
• Infrared thermometers
• Digital thermometers
• Oxygen Concentrators
• Pulse Oximeters (single measurement)
• Aspirators/suction pumps (portable and stationary)
• Laryngoscopes
• Endotracheal tubes
• Manual resuscitation bags (individually or part of a kit)
• Medical Gloves - Examination and Surgical (Nitrile, Vinyl)
• Oxygen Delivery Devices

Class III Medical Devices

• Ventilators (including bi-level positive airway pressure or BiPAP machines)
• Pulse Oximeters (continuous monitoring)
• Vital Signs Monitors
• Dialyzers
• Infusion Pumps
• Anesthesia Delivery Devices

Class IV Medical Devices

• Extracorporeal Membrane Oxygenation (ECMO) Devices