Exact FDA event identifier

Event 96482

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 14, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Z-1640-2025

Recall number: Z-1640-2025
Initiated: March 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Merit Medical Systems, Inc.
Quantity: 1655 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Code information

All Lots/ UDI: 00810275011089

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.

device · product 2 of 2

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

Z-1641-2025

Recall number: Z-1641-2025
Initiated: March 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Merit Medical Systems, Inc.
Quantity: 7453 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Code information

All Lots/ UDI: 00810275014011