Every healthcare organization manages recalls, but not every organization has a defined process for managing them. That distinction can significantly affect patient safety, regulatory compliance, staff workload, and organizational risk.
Through my work with the Recall Management Interest Group (RMIG), I have connected with recall professionals from hospitals and health systems of all sizes. Some have mature, well-established processes. Others are formalizing what they already do or building a defined process for the first time. All can learn from seeing how their peers approach the same challenges.
When a recall arrives, every organization has to respond. What differs is the structure behind that work – who owns it, how consistently it is performed, how it is documented, and how easily the organization can demonstrate what happened.
The real question is not simply whether the recall gets addressed. It is whether a consistent, repeatable, and accountable process helps ensure that it does – every time.
The “We Just Deal With It” Approach
Across healthcare, one common approach is simply to deal with recalls as they arrive. If recalls are getting handled, it can be difficult to see a reason to formalize the process.
The risk is that an informal process may depend heavily on individual knowledge rather than an established workflow. A recall may arrive in Supply Chain, Nursing, Pharmacy, Laboratory, HTM, Quality, Risk Management, Infection Prevention, or several departments at once. Staff may rely on email chains, experience, or simply knowing who to call.
Most of the time, this approach may appear to work, which is exactly why the weakness can be difficult to recognize. If one employee knows where recalls should go and another maintains the tracking spreadsheet, the organization may seem to have a functioning process. That changes when someone is unavailable, leaves the organization, or a high-risk recall affects multiple hospitals and departments at once. Informal processes often work until the recall arrives that exposes everything the organization has been relying on.
Why Recall Ownership Matters
The first step in replacing that vulnerability with a more reliable process is establishing clear ownership.
A healthcare organization should be able to answer one simple question: Who owns recall management?
Ownership does not mean one person performs every task. Recall management is inherently collaborative, and a designated owner is not expected to search every supply room, inspect every medical device, or complete every corrective action.
Ownership means someone is accountable for ensuring recalls are received, assessed, routed, tracked, documented, escalated when necessary, and closed. That responsibility may belong to an individual, department, or multidisciplinary team. The model can vary. The accountability should not.
Without designated ownership, recalls can become everyone’s responsibility and, in practice, no one’s responsibility.
The Cost of Winging It
The cost of an informal recall process extends beyond staff inefficiency. Duplicate work, delayed communication, inconsistent documentation, limited visibility, and incomplete follow-up can increase organizational risk. These weaknesses may remain hidden during routine recalls, but they become much more visible when an event crosses multiple facilities, departments, or product categories.
Without a standard process, staff must repeatedly decide who should receive the notice, who is responsible for taking action, what must be documented, when escalation is necessary, and how completion will be verified. Each recall becomes a new problem to solve rather than a defined process to follow.
Standardization Creates Reliability
Standardization replaces those repeated decisions with an established framework.
A mature recall management approach treats recalls as a defined organizational process rather than a series of isolated events. The product may change. The manufacturer may change. The departments involved may change. The basic workflow should not.
A standardized recall process generally includes:
- Receiving and documenting the notice
- Assessing organizational impact
- Identifying affected products, inventory, assets, and locations
- Identifying and notifying responsible stakeholders
- Assigning and completing corrective actions
- Tracking and documenting responses
- Escalating incomplete or overdue actions
- Verifying completion and closing the recall
Details will vary, but the framework should remain recognizable from one recall to the next. When staff know what happens next, communication and documentation improve, and the organization becomes less dependent on individual memory.
Building a Recall Process Does Not Have to Be Complicated
A strong recall process does not require expensive software or a large team. Technology can support recall management, but it cannot replace a process that has never been defined. Organizations can begin by establishing four foundational elements.
1. Centralize recall intake
Establish a single, consistent entry point for recall notices. A centralized inbox, such as recalls@myhospital.org, gives manufacturers, regulatory agencies, and employees one place to send recall information. It also reduces the likelihood that an urgent notice will remain isolated in a department or individual inbox.
2. Assign recall ownership
Identify the individual, department, or team responsible for overseeing the recall process. Ownership means ensuring the right people are identified, actions are assigned, responses are tracked, and the recall reaches closure.
3. Document the workflow
Define roles, responsibilities, communication expectations, escalation pathways, documentation requirements, and closure criteria. A good test is simple: could someone who did not build the process understand what to do?
4. Measure process performance
Track recall volume, response times, completion rates, overdue actions, and recurring challenges. Organizations cannot improve a process they cannot see, and simple measurements can reveal bottlenecks and opportunities for improvement.
Recall Management Deserves a Defined Process
Healthcare organizations have become increasingly sophisticated in how they manage patient safety, quality, supply chain operations, technology, and risk. Recall management deserves the same attention – whether an organization is defining its process for the first time or refining one already in place.
Provider-to-provider collaboration can make that work easier. Recall professionals often face the same questions but have few opportunities to compare approaches with peers who actually do this work. RMIG and RMIGConnect.com give providers a place to connect, exchange practical tools and ideas, and learn how others have built and strengthened their recall processes.
For an organization without a defined process, that shared knowledge can provide a starting point. For an organization with an established process, it can provide ideas for improving communication, escalation, documentation, measurement, and follow-up.
The products, systems, and organizational structures may differ, but the questions are remarkably similar: Who owns the recall? How do we know who needs to act? How do we know the action was completed? And can we prove it later?
Those are not primarily technology questions. They are process questions – and they are easier to solve when recall professionals do not have to solve them in isolation.
Moving from “winging it” to a standardized recall process is not about adding bureaucracy. It is about creating clarity. The goal is not for every healthcare organization to manage recalls exactly the same way. It is for every organization to have a process it understands, can execute consistently, and can continue to improve by learning from others.
Disclaimer
The views expressed are the author’s personal views, and do not necessarily reflect the policy or position of Mayo Clinic.
Article by:
Amy Conway, M.S.Ed., Enterprise Recall Analyst, Mayo Clinic; Co-Founder, Recall Management Interest Group (RMIG)
Amy Conway is the Enterprise Recall Analyst at Mayo Clinic, with 10 years of experience in Supply Chain Management and more than 30 years in manufacturing and supply chain operations. She co-founded the Recall Management Interest Group (RMIG) in 2022 and now leads the provider-focused collaborative, including RMIGConnect.com, which supports recall professionals through education, shared resources, and provider-to-provider collaboration.
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