The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1096-2025·Announced 2025-02-12

FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals

Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The hazard is theoretical—open seals could allow pathogen contamination and infection if undetected. Per the rubric, this qualifies as High (Score 3) because it involves a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ethicon, LLC is recalling PROLENE polypropylene sutures used in cardiovascular, ophthalmic, and neurosurgical procedures. The recalled units were distributed worldwide.

The sutures have defective primary packaging seals caused by a manufacturing issue on a specific machine. Open seals may allow undetected breaches in sterility, potentially introducing pathogens and causing infection.

A total of 15,948 units of PROLENE sutures with specific reference numbers EH7585H, 8706H, 8833H, 8963H, and 8935H are affected.

Healthcare facilities should verify their inventory against the recalled lots and reference numbers. Contact Ethicon, LLC with questions about affected sutures or the recall.

The recalled product

Product
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Manufacturer
Ethicon, LLC
Category
Medical Device — Surgical Sutures
Hazard
Affected units
15,948

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029)
  • 8706H/10705031019430/103E22(8/31/2029)
  • 103EMJ(8/31/2029)
  • 8833H/10705031021037/103HC4(8/31/2029)
  • 8963H/10705031091931/103E8Z(8/31/2029)
  • 8935H/10705031022089/103HBP(8/31/2029)

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Ethicon, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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