CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Prolene Suture Blue "5/0 Da Rb-2 +plg, D7879 recalled by Ethicon

Ethicon is recalling Prolene Suture Blue "5/0 Da Rb-2 +plg, D7879, distributed in 25 states. The recall was initiated on 7 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKEB378 KKJ784 MCP374

Quantity recalled588

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2454-2018
FDA event ID: 80306
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2018
FDA classified: 17 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

7 May 2018	Recall initiated by company
17 Jul 2018	Classified by FDA	+71 days
25 Jul 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

Where it was distributed

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

Arizona California Colorado Florida Georgia Illinois Indiana Kansas Massachusetts Minnesota Missouri North Carolina Nebraska New Jersey New York Ohio Oregon South Carolina South Dakota Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

KEB378 KKJ784 MCP374

Where was it sold?

Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

18 other products · FDA event 80306

This product is part of a recall event; the main page for the event is Prolene Suture Mono Blue - BV1755 Taper Point 3/8C, D10031 recalled.

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018	CLASS II	Prolene Suture Mono Blue - BV1755 Taper Point 3/8C, D10031 recalled	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture Blue 18" 7-0 D/a Bv-1, Dc631 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Pronova Suture Blue Mono Poly - Sh-1 Taperpoint 1/2C, D10027 recalled	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 36" 4-0 Blue, D9067 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 30" 8-0 Blue, D8292 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 24" 7-0 Blue, D8881 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture Mono Blue BV1755 Taperpoint 3/8C, D9995 recalled	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 36" 4-0 Blue, D7768 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 4-36" 4-0 Blue, D5988 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 4-36" 3-0 Blue, D6416 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 36" 3-0 Blu, D9844 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 24" 6-0 Blue, D8688 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 4" 8-0 Blue, D9662 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 30" 4-0 Blue, D7748 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Pronova Suture Blue M1.5, D10189 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture Blue 4x90cm M1.5 USP 4/0 Da Rb-1 +p, D5981 recalled	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture 30" 6-0 Blue, D8647 recalled by Ethicon	Ethicon	Sterility	25 states
25 Jul 2018	CLASS II	Prolene Suture Blue 48" 4-0 D/a Sh-1, D9746 recalled by Ethicon	Ethicon	Sterility	25 states

More recalls from Ethicon

All 76

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
12 Feb 2025Device	CLASS II	Perma-hand Silk Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Ethibond Excel Polyester Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Prolene Polypropylene Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
27 Nov 2024Device	CLASS II	Monocryl" (poliglecaprone Suture recalled by Ethicon	Ethicon	Packaging Defects	45 states

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide