Draeger Infant Circuit Recall Shows How FDA Ranks Device Recalls

The FDA has classified Draeger's recall of its VentStar Resus Neo breathing circuits as a Class I recall, the agency's most serious category, according to an FDA notice updated on Oct. 2, 2026. The notice says the disposable circuit conveys breathing gas from a source to an infant weighing up to 22 pounds.

FDA's recall database entry, Z-3252-2026, lists 1,063,643 units in commerce, distributed across the United States and in many other countries, and gives the reason as hoses that may crack, leak or detach. The FDA notice says a cracked hose could restrict ventilation or delay therapy, which could lead to desaturation, hypoxia or death. As of Sept. 3, Draeger had reported no serious injuries or deaths linked to the issue, according to FDA. The database entry says Draeger told customers to inspect hoses before use and discard cracked units, and that it will replace affected circuits free of charge once a correction is in place.

The case illustrates two parts of FDA's recall system: the three recall classes, and the newer Early Alert that can come before them.

What the three classes mean

FDA's recall definitions page describes recalls as "actions taken by a firm to remove a product from the market," and says they can happen on a firm's own initiative, at FDA's request or by FDA order. The agency then ranks each recall by the health hazard involved:

• Class I: a "reasonable probability" that using or being exposed to the product will cause serious adverse health consequences or death.
• Class II: use or exposure "may cause temporary or medically reversible adverse health consequences," or the probability of serious consequences is remote.
• Class III: use or exposure "is not likely to cause adverse health consequences."

The same page separates recalls from market withdrawals, which apply when a product "has a minor violation that would not be subject to FDA legal action."

For devices, a recall does not always mean a product leaves the building. FDA's page on corrections and removals distinguishes a removal, the physical movement of a device from its point of use, from a correction, which can mean repair, adjustment, relabeling, destruction or inspection in place. Under 21 CFR Part 806, manufacturers and importers must report certain corrections and removals to FDA "within 10 working days" of starting them. Recalls are usually voluntary, the page says, but section 518(e) of the Federal Food, Drug, and Cosmetic Act lets FDA order a device recall in rare cases where a company does not act on its own.

Where Early Alerts fit

Classification takes time, so FDA now flags some problems earlier. Its Early Alert page says the device center began a communications pilot announced Nov. 21, 2024, and that as of Sept. 29, 2025, "CDRH will now issue Early Alerts for potentially high-risk removals or corrections for all medical devices." An Early Alert can be posted before FDA has determined that a company's action meets the regulatory definition of a recall.

The Draeger notice followed that sequence. FDA issued an Early Alert on Sept. 3, the same day Draeger sent customers a letter, and updated the page on Oct. 2 to report the Class I classification.

FDA's database lists the recall as open, with the cause "under investigation by the firm."