Medical device recalls are at a 15-year high. Is your health system ready to respond?

When a medical device recall notice hits a health system, the clock starts ticking: how quickly can you locate recalled items from supply storage spaces, and how quickly can you identify and contact all patients who have received the affected item?

Historically, the answer has been: not nearly fast enough. At many health systems, supply chain teams must manually audit physical shelves across multiple facilities, while clinical staff painstakingly dig through physical "implant books" and disparate Electronic Health Record (EHR) fields to find matching lot numbers.

The high-stakes escalation of device recalls

Relying on these fragmented, manual tracking workflows is unsustainable, especially as recall volumes grow and healthcare organizations face increasing labor and margin pressures.

In 2024, medical device recalls reached a four-year high (1,059 events), and Class I recalls–the FDA’s most serious designation–hit their highest level in 15 years. Additionally, total units affected by recalls increased 55.4% from 2023 to 2024.

Because a recall might target a widespread product line or a hyper-specific subset of lot numbers, health systems cannot afford an uncoordinated response. Executing precise calls to action — whether that means pulling specific inventory or contacting affected patients to explain risks and next steps — requires immediate, granular visibility into supply use and inventory.

Why legacy systems slow the response

However, most health systems do not have the data they need to execute a rapid, targeted recall response. Supply tracking today typically relies on some combination of barcode scanning, RFID, and manual entry — and each comes with gaps. Barcode and RFID workflows are vulnerable at two manual failure points: flawed or incomplete item master data, and frontline staff scanning or typing the wrong code when multiple barcodes appear on the same package. To keep a procedure moving, busy staff frequently default to manual entry during or after the case, reconstructing what was used from memory and packaging. The longer that reconstruction is delayed, the higher the error rate climbs.

EHR pick lists and physician preference cards compound the problem. Because these often don't reflect what's actually opened and used in a given case, they're an unreliable reference point for confirming whether a specific product was involved. Taken together, these gaps mean that when a specific lot or batch is recalled months later, an EHR query on a mistyped or omitted field can return zero results, falsely indicating the product was never used.

Without a reliable and easily searchable record of supply use — what was used on which patient and what remains on the shelf — the burden shifts to a manual search. Staff must physically check individual labels across multiple storage spaces and cross-reference paper logs or whatever records exist, hoping they've caught everything. This process consumes high-value staff hours, risks leaving recalled items on shelves, and increases organizational vulnerability to litigation and compromised patient safety.

Finding affected patients in minutes, not days

Progressive health systems are eliminating this operational vulnerability by introducing automation directly into the clinical and supply chain workflows. AssistIQ’s computer vision and AI platform, AIQ Capture, solves the data capture problem at the point of care.

Instead of relying on rigid barcode workflows or manual data entry, AssistIQ uses computer vision to instantly recognize implants, tissues, and supplies the moment they are passed under a camera in the operating room or procedural suite. The system automatically captures full Unique Device Identification (UDI) data — including exact lot numbers, serial numbers, and expiration dates — even if the item is missing from the hospital's item master.

By integrating with existing EHR and ERP architectures, AIQ ensures that accurate data flows automatically where it is needed. Supply chain leaders gain complete visibility into current stock location, and clinical/risk teams can quickly identify exactly which patients have received a specific medical device — the highest-stakes step in any recall response.

With this electronic record in place, what used to take days of manual searching — checking paper logs, running EHR queries on incomplete data, and asking clinical teams to identify relevant cases — shifts to running a standard operational report.

—Shannon Holley, VP of Operations for System Surgical Services at ProMedica

The corollary benefit: Proactive expiry management

The same automated data foundation provides an invaluable, proactive defensive layer: preventing expired products from ever reaching a patient.

Because the surgical setting represents an organization's absolute last opportunity to verify a product before use, point-of-use validation acts as a critical safety net. When a health system captures comprehensive data via automation, the system can cross-reference expiration dates in real time.

A nurse educator recalled how she’s seen this guardrail operating in real time:

—Amanda Lanham, Nurse Educator, Owensboro Health

Beyond this real-time safety net, AIQ equips health systems with system-level insights to stop expiration waste before it happens. Centralized dashboards allow supply chain leaders to see all stock at a glance across the enterprise. Utilizing expiry heatmaps and automated alerts, teams can quickly identify implants that are approaching their expiration dates with low forecasted local usage. This allows health systems to act early: rotating stock, prioritizing usage on items expiring first, and reallocating supplies system-wide to drastically reduce write-offs and prevent waste.

A modern standard for clinical readiness

Safeguarding care quality, preserving institutional trust, and maintaining compliance requires an operational infrastructure that moves at the speed of modern healthcare. Shifting away from manual tracking workflows does more than just save hours of administrative friction for perioperative and supply chain teams. It builds an airtight operational shield around your facility, turning a high-stakes, stressful process into a seamless safety check.

By replacing a days-long physical search with a proactive, efficient, and data-driven response, AssistIQ equips health systems with the absolute clarity required to safeguard care quality and eliminate supply chain blind spots. With automated capture at the point of care, operational certainty and clinical quality become a unified, effortless standard.