Reported Nov 27, 2024 · Ongoing

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue…

Ethicon, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ETHICON, INC. · Calle Durango 2751 · Juarez, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • Product NumberY936H
  • UDI-DI code10705031059917
  • Lot NumberTMMDQD
Amount recalled
16,524 devices

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.