The device-ban list has three entries

A recall is corrective action on a device FDA still allows on the market. A ban is different in kind — the device stops being legal to sell at all, anywhere, to anyone. FDA has that power. It has used it three times since the authority existed.

A bar written to be hard to clear

Section 516 of the FD&C Act (21 U.S.C. § 360f) lets FDA ban a device it finds presents substantial deception or an unreasonable and substantial risk of illness or injury that labeling — a warning, an instruction, a contraindication — cannot correct. That last clause is the load-bearing one: if a label could fix the risk, FDA has to require the label, not ban the device. A ban only reaches devices where labeling has already been tried and failed, or plainly cannot work. Getting there is a full notice-and-comment rulemaking — a proposed rule, a public comment period, and a final rule that lists the device in 21 CFR Part 895. Nothing about the process is faster or quieter than reclassifying a device or issuing a recall; it runs on the same rulemaking clock as any other regulation, aimed at a much narrower target.

Three uses in fifty years

FDA banned prosthetic hair fibers— synthetic strands implanted into the scalp to simulate hair — by final rule on June 3, 1983, citing both infection and scarring risk and the fact that the fibers didn’t do what they were sold to do. That rule, codified at 21 CFR 895.101, was the first device FDA ever banned, and it is the one most retellings of this story leave out. The second use came more than three decades later: a final rule effective January 18, 2017 banned powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove, over the powder’s role in adhesions, granulomas, and allergic reactions — codified at 21 CFR 895.102–895.104. Between those two rules and the third, FDA proposed no other device ban at all.

The third one didn’t survive

In 2020, FDA banned electrical stimulation devices used to treat self-injurious or aggressive behavior — devices manufactured and used, by FDA’s own account, at a single facility. The ban applied to that specific intended use only, leaving the same hardware legal for other purposes. The D.C. Circuit vacated it in Judge Rotenberg Educational Center v. FDA on July 6, 2021, holding that Section 516, as it then read, didn’t let FDA ban a device for some intended uses while leaving others untouched — that a use-specific ban functioned as regulating the practice of medicine, which a separate section of the statute puts off-limits to FDA. Congress rewrote Section 516 in the Food and Drug Omnibus Reform Act of 2022 to permit exactly that kind of use-specific ban, and FDA proposed the same ban again under the fixed statute in March 2024. As of this writing, no final rule has issued; FDA’s own regulatory agenda has pushed the target date past its most recent estimate more than once.

Three device bans in fifty years is not a low-activity quarter. It is close to the entire record.

The practice

A published account describing FDA as having “banned” the 2020 device is now describing a rule with no current legal effect — worth checking the date on any such reference before treating it as current. And because a Section 516 ban would reach FDA Radar’s own Federal Register feed as an ordinary Proposed or Final Rule — nothing in the pipeline tags it specially, per what we monitor and how often— the volume itself is the signal worth carrying into a monitoring practice: this is a rulemaking track FDA reaches for less often than almost anything else it publishes, so a proposal that uses it is not routine background noise, whatever else is moving through the docket that week. This is a description of how rarely one statute has been invoked and what happened the one time a use-specific version of it was tried — regulatory intelligence and method, never advice about a specific device’s own risk profile.