A recall is a method of removing or correcting products that violate laws administered by the US Food and Drug Administration (FDA). It is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect public health and well-being from products that present a risk of injury, gross deception or are otherwise defective. 21 CFR Part 7 provides guidance so that responsible firms can carry out recalls effectively.
In rare cases, if a manufacturer or importer fails to voluntarily recall a device that presents a risk to health, the FDA may use the legal authority and procedural framework of 21 CFR Part 810 (Medical Device Recall Authority) to order a mandatory recall.
At a glance: FDA recall classes, how recalls are initiated, company recall strategy and recall depth.
Recall classes
Class I recall
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There is a reasonable probability that the product will cause serious adverse health consequences or death. This is the most serious recall class.
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Handling: the device must be taken out of use and quarantined immediately, and the company must provide an emergency replacement or disposal plan.
For example, in one ventilator recall the FDA required healthcare facilities to contact patients immediately to assess the risk.
Class II recall
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The product may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote.
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Handling: restrict the scope of use or update the operating instructions. For example, a blood glucose meter was subject to a Class II recall due to calibration deviation, and the company had to provide a free software upgrade.
Class III recall
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The product is unlikely to cause adverse health consequences but violates FDA regulations or standards.
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Handling: supplement the labelling or train users. For example, an infusion set was subject to a Class III recall due to unclear instructions, and the company had to supplement the instructions and train users.
How recalls are initiated
Voluntary recalls (the vast majority)
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Initiated by the company itself, usually based on internal quality testing, adverse event reports or FDA advice.
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Process: the company submits a recall plan to the FDA and, after review, issues a public notice covering the affected products, remedies (such as repair or replacement) and customer service channels.
Mandatory recalls (very rare)
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When a company does not recall voluntarily and the product poses a serious health risk, the FDA orders a mandatory recall under Section 518(e) of the Federal Food, Drug, and Cosmetic Act.
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Typical scenarios: the company conceals defects or delays the recall; the defect has already caused multiple deaths or serious injuries (e.g. in 2025 a company’s heart pump was subject to a mandatory Class I recall after 49 deaths).
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Legal consequences: the company may face fines, injunctions or criminal liability, and the FDA will publicise the recall widely through its website and the media.
Company recall strategy
The recalling firm must develop a recall strategy that takes into account the following factors as they apply to the specific recall:
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Results of the health hazard evaluation;
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Ease of identifying the product;
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Degree to which the product’s deficiency is obvious to the consumer or user;
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Degree to which the product remains unused in the marketplace;
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Continued availability of essential products.
The FDA reviews the adequacy of a proposed recall strategy and recommends changes as appropriate. A firm conducting a recall should follow the approved strategy, but need not delay initiating the recall while the strategy is under review.
Depending on the degree of hazard and the extent of distribution, the recall strategy specifies the level in the distribution chain to which the recall is to extend, as follows:
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Consumer or user level, which may vary by product, including any intermediate wholesale or retail level;
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Retail level, including any intermediate wholesale level;
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Wholesale level.
Recall depth
Public warning
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Intended to alert the public that the recalled product presents a serious health hazard; reserved for urgent situations where other means of preventing use of the recalled product are inadequate.
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Usually issued by the FDA after consultation with the recalling firm. If the recalling firm decides to issue its own public warning, it must submit the proposed content and plan to the FDA for review and comment.
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Methods: a warning to the public through the general news media, national or local as appropriate; or a warning to the public through specialised news media (such as professional or trade press), or to specific segments of the population (such as physicians and hospitals).
Effectiveness checks
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Intended to verify that all consignees (at the recall depth specified by the strategy) have received notification of the recall and taken appropriate action.
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Consignees may be contacted by personal visits, telephone calls, letters or a combination of these. The FDA provides guidance, “Methods for Conducting Recall Effectiveness Checks”, on the use of the different methods.
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Effectiveness checks are normally carried out by the recalling firm, with assistance from the FDA where necessary and appropriate.
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The recall strategy specifies the method to be used and the level of effectiveness checks, as follows:
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Level A: 100% of all consignees are to be contacted;
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Level B: some percentage of the total number of consignees, determined case by case but greater than 10% and less than 100%, is to be contacted;
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Level C: 10% of the total number of consignees is to be contacted;
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Level D: 2% of the total number of consignees is to be contacted;
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Level E: no effectiveness checks.
Explanation of commonly confused concepts
Case study: a 2025 ventilator recall
On 4 August 2025 the FDA posted a “recall confirmed” notice on its website for continuous ventilator devices. Below we analyse the reason for the recall, the emergency measures advised to users and the content of the recall letter.
Reason for the recall
A company’s continuous ventilator devices had problems with interruption and/or loss of therapy, and the instructions for use were deficient.
FDA determination
This is a medical device recall involving correction of the device, not its removal from where it is used or sold. The FDA identified this as the most serious type of recall: continued use of the device without correction may cause serious injury or death.
Emergency measures advised to users
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If interruption of therapy can be tolerated and the ventilator gives a ventilator-inoperative alarm, patients/caregivers should remove the patient from the device and use another device.
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If interruption of therapy cannot be tolerated, patients and caregivers should provide back-up ventilation and contact the device supplier for an immediate replacement device.
Content of the company’s recall letter
Recommended actions:
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If a ventilator-inoperative alarm occurs, immediately remove the patient and connect them to an alternative source of ventilation, if available. As an optional step, a “forced restart” of the device may be attempted, which may temporarily restore device function.
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Identify the customer list and, where appropriate, distribute this urgent medical device recall notice and all relevant appendices to physicians, clinicians, patients and/or users.
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Complete and return the response form included with this notice.
Reason for updating the device’s instructions for use:
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The ventilator’s instructions for use did not address the risk of ventilator-inoperative alarm failures, which may lead to interruption or loss of therapy. The device may: intermittently reboot for 5–10 seconds (therapy stops, blank screen, single audible alarm) and then restart with the same patient settings; reboot intermittently for 5–10 seconds (therapy stops, blank screen, single audible alarm) and then restart with factory default settings; or, after three reboots within 24 hours, or without any prior reboot, enter a ventilator-inoperative state (therapy stops, with audible and visual alarms).
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These problems may lead to interruption or loss of therapy, which in vulnerable patients may result in respiratory failure, hypoxaemia, hypercapnia or death.
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13 injuries and 8 deaths have been reported.
Updated device indications for use:
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The BiPAP V30 Auto ventilator provides non-invasive support for obstructive sleep apnoea (OSA) and respiratory insufficiency in adults and children weighing more than 10 kg (22 lb). The device is intended for institutional or hospital use only, not for life support, but may be used during transport within the institution.
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The BiPAP A30 ventilator provides non-invasive support for OSA and respiratory insufficiency in adults and children weighing more than 10 kg (22 lb). It is intended for home use and clinical settings such as hospitals, sleep labs and sub-acute care facilities.
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The BiPAP A40 ventilator provides invasive and non-invasive support for adults and children weighing more than 10 kg (22 lb) for the treatment of sleep apnoea, respiratory insufficiency or respiratory failure. It is not intended for life support or transport, but for home and clinical settings, including portable applications such as wheelchairs and gurneys.
For the original information, see: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
Summary
A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. If the firm takes such action because it believes the product violates the law, it must notify the FDA immediately and contact the Division Recall Coordinator (DRC) of the FDA Office of Regulatory Affairs (ORA) listed for its state or region. Foreign manufacturers and importers should contact the DRC where their US agent is located.
Such a removal or correction is considered a recall only if the FDA determines that the product is in violation. In that case, the FDA will ask the firm for the following information:
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Identity of the product involved;
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Reason for the removal or correction, and the date and circumstances under which the product deficiency or possible deficiency was discovered;
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Evaluation of the risk associated with the deficiency or possible deficiency;
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Total amount of such products produced and/or the time span of production;
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Total amount of such products estimated to be in distribution channels;
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Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts;
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A copy of the firm’s recall communication if issued, or a proposed communication if not yet issued;
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Proposed strategy for conducting the recall;
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Name and telephone number of the firm official to contact concerning the recall.
The FDA reviews the information submitted, advises the firm of the assigned recall classification, recommends appropriate changes to the firm’s recall strategy, and advises the firm that its recall will be listed in the FDA’s weekly Enforcement Report. The firm need not delay removing or correcting the product during the review.
A firm may decide to recall a product when informed by the FDA that the agency has determined the product to be in violation, even if no recall has been specifically requested. If a firm initiates a removal or correction it considers to be a market withdrawal, where the reason for the removal or correction is not obvious or clear-cut but product complaints or adverse reactions suggest the product is deficient in some respect, the firm should consult its Division Recall Coordinator (DRC). In such cases the FDA will help the firm determine the exact nature of the problem.
When a company receives an FDA recall notice, taking the right action is not only a legal obligation but also key to protecting brand reputation and public health.
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