--- title: "Tissue Recall: How An HCT/P Recall Works In 2026" description: "Tissue recall explained: how an HCT/P recall works under FDA rules, what 21 CFR 1271.350 reporting requires, and what a recall would mean for banked tissue." url: "https://savemyfat.com/tissue-recall-hctp-banked-tissue/" --- # Tissue Recalls: How an HCT/P Recall Works and What It Would Mean for Banked Tissue Table of Contents - [Oscar Tellez](https://savemyfat.com/oscar-tellez/) - October 16, 2026 - 10:00 am - [Adipose Banking](https://savemyfat.com/category/adipose-banking/), [Regulation](https://savemyfat.com/category/regulation/) ![Glass front lab cabinet with blue capped cryovials set apart behind a divider, how a tissue recall hold might look](https://savemyfat.com/wp-content/uploads/2026/09/tissue-recall-hctp-banked-tissue-v2.webp)Tissue recalls: how an hct/p recall works and what it would mean for banked tissue 2 Recalls happen in every product category FDA regulates, and human tissue is no exception. This guide explains what a tissue recall is under FDA rules, who can start one, what a bank must report without a recall, and what a recall would mean for adipose tissue stored for one person. **TLDR A tissue recall is a firm’s removal or correction of a marketed product that FDA considers violative. Recalls are usually voluntary under 21 CFR Part 7 and are sorted into three classes by health hazard, but FDA can also order an HCT/P recall under 21 CFR 1271.440. Banks must report serious communicable disease reactions within 15 calendar days and core deviations within 45 days regardless. Banking does not guarantee any future use.** **Important Disclaimer:** Save My Fat does not provide FDA-approved treatments or cures for any disease. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived stem cell product currently has FDA approval for any condition. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions. --- The word “recall” lands hard. Readers weighing adipose tissue banking ask a fair question: could tissue sitting in a freezer be recalled, and what would that look like? The short answer is that the recall system is part of how FDA regulation is designed to work, not a sign that it has failed. How to check whether a bank is legitimate is one of the questions readers bring to this site most often. Save My Fat connects patients and providers with a U.S. tissue bank. It does not collect, process, store, or treat tissue, so this post describes the rules, not any laboratory’s procedures. ## What Is a Tissue Recall Under FDA Rules? A tissue recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers. The definition sits in [21 CFR 7.3](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-A/section-7.3), which states that recall means “a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.” Two neighbors matter. A correction is repair, relabeling, destruction, or inspection of a product “without its physical removal.” A market withdrawal involves a minor or no violation, and the definition says outright that “recall does not include a market withdrawal or a stock recovery.” FDA sorts recalls into three classes by health hazard. The table gives the section 7.3 definitions, which apply to every FDA regulated product, including HCT/Ps. Class Hazard as defined in 21 CFR 7.3 Class I A reasonable probability of serious adverse health consequences or death Class II Temporary or medically reversible consequences, or a remote probability of serious harm Class III Not likely to cause adverse health consequences Read the class as FDA’s weighing of the hazard, not as a count of units involved. --- ## Who Starts a Recall? The firm usually starts a recall on its own, and FDA can also request one. Under [21 CFR 7.40](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C/section-7.40), “recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration.” Under [21 CFR 7.41](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C/section-7.41), an ad hoc committee of FDA scientists evaluates the health hazard. FDA, not the firm, assigns the class. HCT/Ps carry an extra layer. [21 CFR 1271.440](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-F/section-1271.440) applies when FDA has reasonable grounds to believe an HCT/P is violative, infected or contaminated, or that an establishment is violating Part 1271. FDA may then “serve upon the person who distributed the HCT/P a written order that the HCT/P be recalled and/or destroyed, as appropriate.” FDA may also take possession of the HCT/P or order the establishment to cease operations. Orders must state the facts with particularity. An establishment that receives one must make its request within 5 working days of receipt. Our guide to [good tissue practice](https://savemyfat.com/current-good-tissue-practice-cgpt-fda-standard-lab/) covers the everyday rules that apply long before any order is written. --- ## What Must a Bank Report Even When There Is No Recall? A bank must report serious communicable disease adverse reactions and core current good tissue practice deviations to FDA, on fixed clocks, whether or not any recall follows. The rule is [21 CFR 1271.350](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-E/section-1271.350). The first clock covers adverse reactions involving a communicable disease that are fatal, life threatening, result in permanent impairment, or require medical or surgical intervention. Those go to FDA on Form FDA 3500A “within 15 calendar days of initial receipt of the information.” That fits Part 1271 as a whole, which addresses communicable disease, not clinical value. The second clock covers deviations from core current good tissue practice requirements, reported on Form FDA 3486 “within 45 days of the discovery of the event.” A deviation report is not a recall; it is a record that something departed from the rules and that FDA was told. Storage has its own trigger. Under [21 CFR 1271.260](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-D/section-1271.260), a bank “must establish acceptable temperature limits for storage of HCT/Ps at each step of the manufacturing process” and “must maintain and record storage temperatures.” When storage conditions are not met, corrective action must be taken and documented. Our post on [sterility testing](https://savemyfat.com/sterility-testing-adipose-tissue-banking/) covers a related control that also generates records. --- ## How Does Tracking Make a Tissue Recall Possible? Tracking makes a tissue recall possible because every HCT/P must carry a distinct identification code. That code links the tissue to its donor and to every record about it. Under [21 CFR 1271.290](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-D/section-1271.290), the system must enable tracking “from the donor to the consignee or final disposition” and back again. The code may be alphanumeric, and it may not include a name, social security number, or medical record number except where section 1271.55(a)(1) allows. Without tracking, a recall would be guesswork. With it, a bank can identify which units an event affected, where each one is, and whose it is. That is why the [chain of custody](https://savemyfat.com/chain-of-custody-for-adipose-tissue-what-to-know/) for your tissue is worth asking about before you sign. --- ## What Would a Recall Mean for Banked Autologous Tissue? For banked autologous tissue, a recall or deviation would mean the bank identifies the affected units through its tracking system and takes and documents corrective action. Its own procedures and the storage agreement then govern what happens next. The tissue is traceable to one person and has not been distributed to anyone else. Three points follow. First, the recall definition in section 7.3 speaks of a “marketed product,” and section 1271.440 directs an order to “the person who distributed the HCT/P.” Tissue stored for its own donor and never released sits in a different factual position from a product shipped to many recipients. Whether an event is handled as a recall, a correction, or a deviation report is a question the bank and FDA answer on the facts. Second, a deviation can affect more than one unit. A storage temperature excursion can touch every unit in that location, and tracking then tells the bank which codes, and therefore which donors, are involved. Third, the sections cited in this post set no rule for telling a patient that their stored autologous tissue was affected. Section 1271.260 requires corrective action and records, and section 1271.290 requires written notice of the tracking system to consignees. Neither spells out patient notification, so the bank’s standard operating procedures and your storage agreement govern that. So ask the bank in writing. How would you learn that a stored unit was affected? How and when would you be told? What happens to the tissue and the fees if a unit must be destroyed? Our [patient guide](https://savemyfat.com/what-happens-to-your-adipose-tissue-patient-guide/) to banked tissue lists other questions worth asking. Banking preserves your own tissue, and any future use depends on regulatory status and physician guidance at that time. --- ## Where Are Recalls Published? FDA publishes recalls on two public pages. The [Recalls (Biologics)](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/recalls-biologics) page lists postings by year with no separate HCT/P category. The weekly [Enforcement Reports](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports) cover all FDA monitored recalls, whether Class I, II, III, or not yet classified. The biologics page also notes “a trial pilot program to expedite notifications of Non-Blood (HCT/P, Vaccine, Derivative, etc.) product recalls to the public.” When that [pilot page](https://www.fda.gov/safety/enforcement-reports/non-blood-product-going-recalls) was checked in September 2026, it showed no tissue recalls. That is a snapshot, not a promise. --- ## Frequently Asked Questions ### Can tissue that has never left the freezer be recalled? The recall definition in 21 CFR 7.3 speaks of a marketed product, and a 1271.440 order goes to the person who distributed the HCT/P. Stored autologous tissue has not been distributed. A storage problem would more likely be handled as a deviation with corrective action and records. How a specific event is classified is a decision for the bank and FDA. ### How do I check a bank’s recall history? Search the FDA Recalls (Biologics) page and the weekly Enforcement Reports by the establishment’s legal name. A deviation filed on Form FDA 3486 is a report to FDA, not a recall, so also ask the bank in writing whether it has had any recall, correction, or reportable deviation. --- ## Key Takeaways A tissue recall is a firm’s removal or correction of a marketed product that FDA considers violative. FDA sorts recalls into Class I, II, or III by health hazard. Recalls are usually voluntary under Part 7, and FDA can order an HCT/P recall under section 1271.440. A bank must report serious communicable disease reactions within 15 calendar days and core deviations within 45 days regardless. A distinct identification code ties every unit to its donor. For stored autologous tissue, the cited sections set no patient notification rule, so the storage agreement governs, and banking guarantees no future use. Save My Fat connects patients and providers with a U.S.-based tissue bank. It is not a tissue bank, a laboratory, a medical practice, or a treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, California, Georgia, and Tennessee governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time. Readers weighing adipose tissue banking for potential future use can review [current pricing](https://savemyfat.com/pricing/) or bring their recall questions to the [contact page](https://savemyfat.com/contact-us/). --- *Save My Fat works with a U.S.-based tissue bank for laboratory processing and storage.* *This article is for educational purposes only and does not constitute medical or legal advice. Please consult your own licensed healthcare provider before making any decisions about treatment or research participation.* **About the author:** Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice. **Related guide:** [FDA adipose tissue regulation](https://savemyfat.com/fda-regulation-adipose-tissue/). Follow Save My Fat on Google Set us as a preferred source and Google will show our latest updates more often in your results. [PrevPreviousWhich States License Tissue Banks, and Why It Matters for Your Banked Tissue](https://savemyfat.com/tissue-bank-licensing-by-state/) [NextFDA’s 2026 Plausible Mechanism Draft Guidance: What It Could Mean for Autologous CellsNext](https://savemyfat.com/plausible-mechanism-guidance-fda-2026/) Adipose Banking ### [What Happens to Banked Tissue If You Die: Next of Kin, Directives, and the Storage Agreement](https://savemyfat.com/banked-tissue-succession-planning/) [Read More »](https://savemyfat.com/banked-tissue-succession-planning/) Oscar Tellez 10/22/2026 10:00 AM Regulation ### [FDA’s Tissue Reference Group: Who Decides Whether a Tissue Product Is 361 or 351](https://savemyfat.com/tissue-reference-group-fda-361-351/) [Read More »](https://savemyfat.com/tissue-reference-group-fda-361-351/) Oscar Tellez 10/21/2026 10:00 AM Adipose Banking ### [Cord Blood Banking vs Adipose Banking: What Applies to You as an Adult](https://savemyfat.com/cord-blood-vs-adipose-banking/) [Read More »](https://savemyfat.com/cord-blood-vs-adipose-banking/) Oscar Tellez 10/20/2026 10:00 AM Regulation ### [FDA’s 2026 Plausible Mechanism Draft Guidance: What It Could Mean for Autologous Cells](https://savemyfat.com/plausible-mechanism-guidance-fda-2026/) [Read More »](https://savemyfat.com/plausible-mechanism-guidance-fda-2026/) Oscar Tellez 10/19/2026 10:00 AM [![Glass front lab cabinet with blue capped cryovials set apart behind a divider, how a Tissue Recall hold might look](https://savemyfat.com/wp-content/uploads/2026/09/tissue-recall-hctp-banked-tissue-v2-768x768.webp)](https://savemyfat.com/tissue-recall-hctp-banked-tissue/) Regulation ### [Tissue Recalls: How an HCT/P Recall Works and What It Would Mean for Banked Tissue](https://savemyfat.com/tissue-recall-hctp-banked-tissue/) [Read More »](https://savemyfat.com/tissue-recall-hctp-banked-tissue/) Oscar Tellez 10/16/2026 10:00 AM [![United States map with brass pins and red string on a walnut table, a picture of Tissue Bank Licensing by state](https://savemyfat.com/wp-content/uploads/2026/09/tissue-bank-licensing-by-state-v2-768x768.webp)](https://savemyfat.com/tissue-bank-licensing-by-state/) Regulation ### [Which States License Tissue Banks, and Why It Matters for Your Banked Tissue](https://savemyfat.com/tissue-bank-licensing-by-state/) [Read More »](https://savemyfat.com/tissue-bank-licensing-by-state/) Oscar Tellez 10/15/2026 10:00 AM ```json [{"@context":"https:\/\/schema.org","@graph":[{"@type":"BreadcrumbList","@id":"https:\/\/savemyfat.com\/tissue-recall-hctp-banked-tissue\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":"1","item":{"@id":"https:\/\/savemyfat.com","name":"Home"}},{"@type":"ListItem","position":"2","item":{"@id":"https:\/\/savemyfat.com\/our-blog\/","name":"Our Blog"}},{"@type":"ListItem","position":"3","item":{"@id":"https:\/\/savemyfat.com\/category\/regulation\/","name":"Regulation"}},{"@type":"ListItem","position":"4","item":{"@id":"https:\/\/savemyfat.com\/tissue-recall-hctp-banked-tissue\/","name":"Tissue Recalls: How an HCT\/P Recall Works and What It Would Mean for Banked Tissue"}}]}]},{"@context":"https:\/\/schema.org","@graph":[{"@type":"Person","@id":"https:\/\/savemyfat.com\/oscar-tellez\/#person","name":"Oscar Tellez","jobTitle":"Founder","description":"Oscar Tellez is the Founder of Save My Fat, a company that connects patients and physicians with a U.S. tissue bank for adipose tissue banking, so a person's own tissue can be preserved for potential future use in FDA-regulated pathways. 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