When your vendor's recall hits,
your team has hours — not days.

Manufacturers have crisis firms. Regulators have enforcement tools. Your facility has a spreadsheet and a point person who hasn't slept. RecallWire gives healthcare teams the infrastructure to respond in hours, with a complete audit trail — automatically.

No credit card required · Implementation support included

The 2025 Recall Reality
123
Class I recalls in 2025, up from 114 in 2024
978
Total FDA medical device recalls in 2025
90%+
Reduction in time spent processing recalls with RecallWire
The Facility-Side Problem

Speed without infrastructure
is just controlled chaos.

Your vendor has a crisis plan. Do you?

When a high-profile medical device recall hits, manufacturers activate emergency response infrastructure — crisis communications firms, regulatory counsel, dedicated call centers. Their goal: manage outbound messaging and protect their brand.

Your goal is different. You need to identify every affected device across every location, notify the right people, document every step, and produce an audit-ready trail — before the Joint Commission asks.

With manual processes, that takes 20–40 hours. With a Class I recall, you may not have that long.

Joint Commission Standard EC.02.01.01 requires documented recall monitoring. Most facilities have a process. Very few have infrastructure. The difference matters when a recall arrives on a Friday afternoon and your distributor's line goes to voicemail.

Identification Gap
Thousands of medical device recall alerts each year. Only 2-5% apply to your inventory, but your team has to check every one. Manual cross-reference against purchase history can take days.
Routing Failure
The right department, the right staff, the right vendor contact — all require manual coordination. One missed notification is a compliance gap.
Documentation Debt
EC.02.01.01 EP 11 requires full traceability. Emails, spreadsheets, and handwritten logs don't hold up under audit. The documentation burden compounds with every open recall.
No Vendor Safety Net
When a manufacturer's recall response collapses — overwhelmed call centers, delayed replacement inventory, unclear instructions — your team absorbs the fallout. Alone.
Illustrative Scenario

How a 12-location health system
responded to a Class I recall in 4 hours.

Class I Recall Event
The manufacturer notified facilities at 4:47pm on a Friday. Replacement inventory was unavailable. Their response line had a 90-minute hold time.

A leading surgical instrument manufacturer issued an urgent Class I recall — reasonable probability of serious injury. Public notification was required immediately, before remediation plans or replacement stock were in place. The facility's Materials Manager received the alert at 4:47pm on a Friday. With 12 locations, 340 affected lot numbers, and a Joint Commission survey scheduled for the following month, the clock was running.

Without infrastructure, this would have taken 40+ hours across a weekend — manual PO history lookups, emails to department heads, phone calls to a vendor hotline with a 90-minute hold time. With RecallWire, the response was complete in under 4 hours, with a full audit trail ready for the surveyors.

What RecallWire Did — Automatically
  • Matched 340 lot numbers against PO history across all 12 locations in minutes — not hours
  • Routed alerts to Materials Management, OR leadership, and Risk Management simultaneously
  • Triggered a guided resolution workflow with step-by-step documentation built in
  • Generated EC.02.01.01-compliant audit documentation in real time
  • Flagged open inventory for quarantine and tracked disposition through resolution
What the Team Focused On
  • Patient communication — knowing exactly which procedures involved affected devices
  • Vendor escalation — with documentation ready, the conversation with the manufacturer was specific and productive
  • Replacement procurement — directed to available substitutes within the same session
  • Surveyor preparation — audit package ready before the Joint Commission visit
4 hrs
Full recall response — down from 40+ hours
98%
Of irrelevant alerts filtered before reaching the team
100%
Audit traceability — EC.02.01.01 ready
0
Gaps found by Joint Commission surveyors
Built for Healthcare Facilities

The infrastructure your vendors
already have — now on your side.

10×
Faster recall response — 40 hours reduced to 4
98%
Alert noise eliminated before it reaches your team
747%
ROI for mid-size health systems (50 locations)
4–8 wk
Implementation — vs. 6+ months for legacy systems
A Managed-Service Option

Don't have the bandwidth?
Let our team run recalls for you.

Most facilities buy the platform and run it in-house. But if your team is already at capacity, RMaaS gives you the same outcome without adding headcount: our recall specialists triage alerts, manage workflows, communicate with vendors, and produce audit documentation on your behalf.

RMaaS Recall Management as a Service. The RecallWire platform plus a dedicated specialist who handles the work end to end, so your staff stays focused on patient care.
Entry
Essentials
Daily triage and weekly reporting. Best for single-site facilities that need oversight but not full-time management.
  • Daily alert triage by a RecallWire specialist
  • Weekly status report delivered to your team
  • Platform access for your staff
Full Service
Complete
Dedicated specialist handling vendor communication and audit support. Best for IDNs and complex multi-site systems.
  • Everything in Core
  • Dedicated recall specialist for your account
  • Vendor communication on your behalf
  • Audit support and survey-ready documentation
Melonie Burnett
Connect with me on LinkedIn
15 min No-pressure intro call
Your point of contact
Melonie Burnett, MBA, PhD
Vice President of Business Development, RecallWire

Melonie works directly with healthcare facilities navigating recall management — from community hospitals running a single spreadsheet to IDNs managing multi-site compliance across dozens of locations.

Her focus: understanding where your team's process breaks down under pressure, and showing exactly how RecallWire closes that gap. No deck, no pitch — just an honest conversation about what recall readiness looks like in practice.

If you got a vendor recall notice recently and your first instinct was to open a spreadsheet, that's the conversation worth having.

Request a call or schedule a 15-minute walkthrough with Melonie
Book Time with Melonie →

See RecallWire in 15 minutes — no deck, just the product.

We'll walk through your current recall process, show you exactly where the gaps are, and demonstrate how RecallWire handles a live recall scenario for your facility type.

  • AI inventory matching — watch it eliminate 98% of irrelevant alerts against your device categories
  • Guided resolution workflow — see how EC.02.01.01 documentation is generated automatically
  • Audit trail export — see exactly what a Joint Commission surveyor sees
  • Pricing that fits your facility
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Ready to modernize recalls?