The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1515-2025·Announced 2025-04-09

Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect

Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.

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 recall involves a risk-of-harm product—surgical sutures with a manufacturing defect affecting the silicone in the needle portion. Under the recall severity rubric, manufacturing defects in surgical devices that could affect performance during medical procedures constitute a High severity rating.

Plain-English summary

Ethicon Endo Surgery, LLC is recalling 37,080 units of PROLENE BLU surgical sutures due to identified curing issues with the silicone during the needles manufacturing process. The affected product is PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM.

The recalled sutures have been distributed worldwide, including to the United States and to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, and Uruguay.

The affected lot numbers are: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, and 104SER. The product codes are 8706H-15 and 8711H-16.

The recalled product

Product
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Manufacturer
Ethicon Endo Surgery, LLC
Category
Medical Device — Surgical Sutures
Hazard
Affected units
37,080

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 (15)

  • Product Code: (1) 8706H-15
  • (2) 8711H-16
  • GMDN: 13909
  • UDI-DI: (1) 10705031019430
  • (2) 10705031019560
  • Lot number: 104E88
  • 104E89
  • 1047TZ
  • 104BQ0
  • 104DA2
  • 104JAR
  • 104JPJ
  • 104SES
  • 104KHD
  • 104SER

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Ethicon Endo Surgery, 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 4 products in this recall →

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