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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95583

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

Open FDA event record

Event summary

Timeline bucket
October 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ETHICON, 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

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

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

Z-0487-2025
Recall number
Z-0487-2025
Initiated
October 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
ETHICON, INC.
Quantity
16,524 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Code information

Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD

Distribution pattern

U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, 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 WY. O.U.S.: Not provided.