Exact FDA event identifier

Event 95671

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 21, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: MEDLINE INDUSTRIES, LP - Northfield

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

1 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 1

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

Z-0465-2025

Recall number: Z-0465-2025
Initiated: October 21, 2024
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 69,611

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

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

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

Code information

UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787

Distribution pattern

US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.