FDA · guide
What a Class I Device Recall Obligates a Manufacturer to Do: 21 CFR Part 806 Corrections and Removals
Updated
The vocabulary first
FDA defines a recall as 'a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation' of the law, and a Class I recall as 'a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death' (21 CFR 7.3). For devices, Part 806 uses parallel terms. A correction is 'the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal', and a removal is the physical removal of the device to another location for those purposes (21 CFR 806.2). The Part 806 definition of 'risk to health' tracks the Class I and Class II recall definitions, which is why FDA states that reports of corrections and removals are required for Class I and Class II recalls but not for Class III (FDA: Recalls, Corrections and Removals).
Recall is voluntary, but it is not optional in practice
Under 21 CFR 7.40, recall 'is a voluntary action' and 'an alternative to a Food and Drug Administration-initiated court action', and it may be undertaken at any time by the firm or 'at the request of the Food and Drug Administration'. Seizure or other court action 'is indicated when a firm refuses to undertake a recall requested by' FDA. Part 7 is guidance for how FDA expects a recall to run; Part 806 is the binding reporting rule.
Obligation 1: report to FDA within 10 working days
A manufacturer or importer 'shall submit a written report to FDA of any correction or removal of a device' initiated 'to reduce a risk to health posed by the device' or 'to remedy a violation of the act caused by the device which may present a risk to health', and must do so 'within 10-working days of initiating such correction or removal' (21 CFR 806.10(a)-(b)). The statutory basis is section 519(g) of the FD&C Act (21 U.S.C. 360i(g)). The report under 806.10(c) must include the firm's registration number, device identification including brand name, classification and UDI, marketing status, a description of the event and the corrective action, any illnesses or injuries with related MDR numbers, the number of units and lots affected, manufacturing and distribution dates, consignee names and addresses, and copies of all communications. If the action is later extended to more lots, an amendment is due within another 10 working days under 806.10(d). Submitting the report 'does not necessarily reflect a conclusion' that the device caused a death or injury (806.10(e)).
What is exempt
Section 806.1(b) exempts four kinds of action from reporting: changes 'to improve the performance or quality of a device but that do not reduce a risk to health', market withdrawals, routine servicing and stock recoveries (21 CFR 806.1). A separate exemption in 806.10(f) provides that 'no report of correction or removal is required under this part, if a report of the correction or removal is required and has been submitted under parts 803 or 1004'. FDA adds that an action ordered by FDA under Part 810 is also outside Part 806 reporting (FDA: Recalls, Corrections and Removals). In a genuine Class I situation, none of the 806.1(b) exemptions will apply.
Obligation 2: keep records of everything you did not report
For any correction or removal that is not reported, 21 CFR 806.20 requires a record containing the device identification and product code, UDI or lot and serial numbers, a description of the event and the action, a justification for not reporting reviewed by a designated person, and copies of communications. Records must be kept 'for a period of 2 years beyond the expected life of the device', and they transfer to any successor manufacturer or importer. FDA can inspect them under 806.30.
Obligation 3: run the recall the way Part 7 describes
A firm that starts a recall should 'notify immediately' its FDA district office and supply the nine items listed in 21 CFR 7.46: product identity, the reason and how the defect was found, a risk evaluation, quantities produced and in distribution, the number and identity of direct accounts, the recall communication, a proposed recall strategy and a contact. FDA then performs a health hazard evaluation under 21 CFR 7.41, weighing whether injuries have occurred, the populations at risk, the seriousness, likelihood and consequences of the hazard, and assigns the class. The firm 'need not delay' initiating the recall while FDA reviews.
The recall strategy under 21 CFR 7.42 sets three things: the depth of recall (wholesale, retail or user level), whether a public warning is needed, and the level of effectiveness checks, from Level A (100 percent of consignees contacted) through Level B, C (10 percent) and D (2 percent) to Level E (no checks). Class I recalls are typically run to the user level with a public warning and a high check level, but the class does not fix these by rule; FDA reviews the strategy case by case. Recall communications under 7.49 must clearly identify the product, explain the reason and hazard, and give specific instructions; follow-ups go to anyone who does not respond.
Obligation 4: status reports until termination
21 CFR 7.53 calls for periodic status reports, 'generally' every 2 to 4 weeks, covering consignees notified, responses, products returned or corrected, effectiveness-check results and the estimated completion time. Reports stop when FDA terminates the recall. Under 21 CFR 7.55, termination occurs when FDA determines that 'all reasonable efforts have been made to remove or correct the product'; the firm can request it in writing with its latest status report and a description of product disposition.
The MDR interplay under Part 803
A Class I event almost always begins as a reportable adverse event. Manufacturers must file an MDR within 30 calendar days of becoming aware that a device may have caused or contributed to a death or serious injury (21 CFR 803.50), and within 5 work days when the event 'necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health' (21 CFR 803.53). The Part 806 report should cite those MDR numbers, and where the correction or removal itself was already described in a required Part 803 report, 806.10(f) removes the duplicate filing.
When FDA takes over: section 518(e) and Part 810
If a firm will not act, FDA can. Where FDA finds 'a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death', it may order the firm to cease distribution immediately and to notify health professionals and user facilities to stop using the device (21 U.S.C. 360h(e); 21 CFR 810.10). The statute promises an informal hearing no later than 10 days after the order. Under 21 CFR 810.13, FDA amends the order into a mandatory recall within 15 working days of the order if no hearing is requested, or of denying or completing one. FDA describes this as reserved for 'rare instances'.
Timeline summary
| When | Obligation | Source |
|---|---|---|
| Immediately | Notify FDA district office, supply 7.46 information | 21 CFR 7.46 |
| 5 work days | MDR if remedial action needed to prevent unreasonable risk | 21 CFR 803.53 |
| 10 working days | Part 806 report of correction or removal | 21 CFR 806.10(b) |
| 30 calendar days | MDR for death or serious injury | 21 CFR 803.50 |
| Every 2 to 4 weeks | Recall status reports | 21 CFR 7.53 |
| Until termination | Effectiveness checks per strategy | 21 CFR 7.42 |
| 2 years past device life | Retain records of unreported actions | 21 CFR 806.20 |
RegPing's FDA bot delivers Class I recall and Enforcement Report notices into Discord so recall teams see FDA's classification the week it posts.
Where to verify
- 21 CFR Part 806, section 806.10 reports of corrections and removals
- 21 CFR 806.1 scope and exemptions
- 21 CFR 806.20 records
- 21 CFR 7.42 recall strategy
- 21 CFR 810.13 mandatory recall order
- 21 U.S.C. 360h(e) recall authority
- FDA: Recalls, Corrections and Removals (Devices)
This guide is general information, not legal advice. Verify against the primary source and consult counsel before acting.
Questions people ask
How quickly must a device manufacturer report a recall to FDA?
Under 21 CFR 806.10(b), a report of a correction or removal initiated to reduce a risk to health is due within 10 working days of initiating the action. Extensions to more lots require an amendment within another 10 working days.
Does a Class III device recall need a Part 806 report?
FDA states that Part 806's 'risk to health' definition tracks Class I and Class II recalls, so Class III actions are not reportable under 806.10, but records must be kept under 806.20.
Can FDA force a device recall?
Yes. Section 518(e) and 21 CFR Part 810 let FDA order a firm to cease distribution and notify users when there is a reasonable probability of serious adverse health consequences or death, and then amend the order into a mandatory recall.