Built for FDA Recall Compliance

Catch the recalled devices
others miss.

Upload your purchase history. ReCheck matches it against 68,580+ FDA recall records and shows you exactly which products need attention — and why.

68,580
FDA Recalls Indexed
82,059
Product Codes Mapped
< 2 min
Time to Results

Patient safety is our core mission

Every recalled device that goes undetected in a hospital is a risk to someone's life. ReCheck exists to close the gap between an FDA recall announcement and the moment a clinician stops using that device.

Hospitals manage tens of thousands of unique products across departments, warehouses, and surgical trays. Manually cross-referencing each one against FDA recalls is slow, error-prone, and often happens too late. We built ReCheck so that no patient is ever exposed to a recalled device because the paperwork didn't keep up.

The average hospital uses 5,000 to 10,000 unique medical devices. When a recall hits, the question isn't whether you have it — it's how fast you can find out.

The problem ReCheck was built to solve
4,000+
FDA device recalls
issued per year
70%
of hospitals still rely on
manual recall checks
6 hrs
ReCheck monitors for
new recalls automatically
< 2 min
From upload to
prioritized action list
How It Works
From purchase file to prioritized report

Upload your data, let ReCheck cross-reference it against the FDA recall database, and review a single sortable report that tells you which devices need attention first.

1

Upload your file

Drop in an Excel or CSV of purchase history. ReCheck auto-detects your columns or lets you map them. A downloadable template with the required layout is available on the upload page.

2

Matching engine runs

Catalog numbers are normalized and checked against labeled REF, CAT, UPN, and model codes in every FDA recall. Manufacturer names and product descriptions are scored to boost confidence and reject false positives.

3

You get a ranked report

An Excel workbook grouped by urgency, with recall class, match score, a plain-English recommendation, and a direct link to the FDA record. Stored inventories are also re-checked automatically when new recalls post.

Result Grouping
How results are ranked

Results are grouped first by FDA recall class — the severity level FDA assigns to each recall — then within each class, sorted by match confidence. Class I always sits at the top of the report.

Class I

Most serious

Reasonable probability of serious adverse health consequences or death. Always appears at the top of the report. A Class I match with strong confidence triggers a "Stop Use" recommendation and a push notification.

Class II

Moderate severity

May cause temporary or medically reversible adverse health consequences. Remote probability of serious consequences. Reviewed after Class I; handle according to the recommended action on each line.

Class III

Low severity

Unlikely to cause adverse health consequences but violates FDA law or regulation. Usually labeling or documentation issues. Lowest priority on the report but still worth tracking for compliance records.

Within Each Class

Sorted by match confidence

Every matched line gets a score from 0 to 1 based on how well your catalog number, manufacturer, and description line up with the recall. Within each class group, higher-confidence matches appear first.

Score 0.85+
Confident match
Catalog number hit a labeled product code in the recall and the manufacturer lined up. Reliable for clinical action.
Score 0.50–0.84
Likely match
Partial supporting evidence — manufacturer overlap or description similarity. Usually real but worth a human glance.
Score <0.50
Possible match
Number appears in recall text without labeled-code or manufacturer confirmation. Requires manual verification.
File Requirements
Required and recommended columns

Two columns are required to run a match. The rest are optional but make the report more useful — more detail per line means better scoring and clearer triage.

ColumnStatusWhat it's used for
Catalog NumberRequiredPrimary identifier matched against labeled codes in each FDA recall. The match will not run without it.
Manufacturer NameRequiredUsed to confirm matches and suppress false positives when the same catalog number shows up across unrelated vendors.
Mfr Catalog NumberRecommendedSecondary catalog number (manufacturer's own code vs. your internal SKU). Widens the match surface so more recalls are caught.
Product DescriptionRecommendedText from your line item. Used for description similarity scoring and to display human-readable context in the report.
PO NumberRecommendedGrouping key in the report so you can trace each match back to the purchase that brought it in.
PO DateRecommendedUsed in the timeline view to show when affected devices entered your inventory.
Unit PriceRecommendedRolled into the financial impact summary on the report.
Vendor NameRecommendedDistributor or supplier. Helps distinguish manufacturer from reseller when issuing recall notices to your supply team.
Supported Formats
Upload what you already have

Export from your ERP, your spend analytics tool, or any spreadsheet. As long as the required columns are present, ReCheck will read it.

XLSX

Excel workbook

First sheet is read. Headers on the first row. Multi-row header exports are supported via the column mapper.

CSV

CSV export

Comma-separated values with a header row. Common delimiters and BOM encodings are auto-detected.

TXT

Pipe-delimited item master

Positional item-master files (one record per row, pipe-separated) are supported for bulk catalog imports.

Ready to screen your supply chain?

Upload your file and get a prioritized recall report in under two minutes.

Start Recall Screening

RecCheck Assistant

AI-powered recall & compliance help

Hi! I'm your ReCheck Assistant

I can help with recall questions, compliance tracking, navigating the app, and understanding your alerts.