Exact FDA event identifier

Event 96555

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

Event summary

Timeline bucket: March 28, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Stryker GmbH

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

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Z-1620-2025

Recall number: Z-1620-2025
Initiated: March 28, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Stryker GmbH
Quantity: 1588 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Code information

Catalog number/REF: 2351-3080S; UDI-DI: 07613327361797; Lot #: KU155697, KU155698, KU155699, KU155700, KU155701, KU155702, KU155703, KU155704, KU155705, KU155706, KU155707, KU155708, KU155709, KU155710, KU155711, KU155712.

Distribution pattern

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

device · product 2 of 2

Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Z-1621-2025

Recall number: Z-1621-2025
Initiated: March 28, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Stryker GmbH
Quantity: 6407 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Code information

Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: KU164143, KU164755, KU164756, KU164757, KU164758, KU164759, KU164760, KU164761, KU164762, KU164763, KU164764, KU164765, KU164766, KU164767, KU164768, KU164769, KU164770, KU164771, KU164772, KU164773, KU164774, KU164775, KU164776, KU164777, KU164778, KU164779, KU164780, KU164781, KU164782, KU164783, KU164784, KU165161, KU165162, KU165163, KU165164, KU165165, KU165166, KU165167, KU165168, KU165169, KU165170, KU165171, KU165172, KU165173, KU165174, KU165175, KU184035, KU184036, KU184039, KU184041, KU184042, KU184044, KU184045, KU184046, KU184047, KU184049.

Distribution pattern

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.