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Lower risk Medical device recall · FDA · Published May 7, 2018

Ethicon PROLENE Suture Monobundle Packaging Risk: Soft Tissue Injury or Infection

Ethicon recalls PROLENE Suture Monobundle (BV1755 Taper Point 3/8C, D10031) due to packaging perforation risk. Perforated packaging may cause soft tissue injury or patient infection if sterility is breached.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2448-2018Medical deviceEthicon ›
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Contact the company

Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
✎ GovInfoNow plain-language explainer

Ethicon is recalling specific PROLENE sutures because their packaging can tear easily, potentially causing injuries to healthcare workers or infections in patients if the tear isn't noticed. Read more at govinfonow.com/recall/71174-ethicon-prolene-suture-monobundle-packaging-risk-soft-tissue-injury-or.

Source Summary by GovInfoNow · govinfonow.com/recall/71174-ethicon-prolene-suture-monobundle-packaging-risk-soft-tissue-injury-or · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2448-2018

Cite this page

“Ethicon PROLENE Suture Monobundle Packaging Risk: Soft Tissue Injury or Infection.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71174-ethicon-prolene-suture-monobundle-packaging-risk-soft-tissue-injury-or. Based on FDA recall #Z-2448-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2448-2018%22&limit=1).

Ethicon, Inc. recalled PROLENE SUTURE MONO BLUE products on May 7, 2018, according to the FDA. The needles may perforate packaging, risking healthcare worker injury or patient infection from sterility breaches.

How to tell if you have it

  • Brand: Ethicon
  • Product: PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031; KDJ805 KDP827 LBB354 MAP602
  • Quantity: 1752 units

The hazard

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.

Context

Ethicon, Inc. has 25 other recalls on record since Aug. 17, 2017. Other recent recalls include Ethicon Monocryl Sutures (Oct. 8, 2024), Ethicon Coated VICRYL Suture (Sept. 25, 2024), and Ethicon VICRYL Suture (May 10, 2024). Similar product recalls include Covidien Surgipro SP-623 Sutures (June 24, 2026), Covidien Surgipro II S8698GX (June 24, 2026), and Covidien Dermalon 4-0 Blue 75cm Sutures (June 24, 2026).

How to tell if you have this one

Check for the product code BV1755 Taper Point 3/8C, D10031 on the packaging. The recalled items were sold under specific model numbers: KDJ805, KDP827, LBB354, MAP602.

  • Brand
    Ethicon
  • Category
    Medical device
FDA recall event · 19 products

All 19 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-2448-2018PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031; KDJ805 KDP827 LBB354 MAP6021752
Z-2449-2018PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981; KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH2881728
Z-2450-2018PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988; KEB377 KEH280 KGP662 KMJ048 KPP500 LCH042 LHP301 LJE786 LPB869 MAH170 MCH330 MCQ9924452
Z-2451-2018PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416; KEH479 KHH259 KLH655 KMH715 LCH548 LHP422 LJJ896 MAR8843024
Z-2452-2018PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748; KDH853 KKH769 KLQ193 KPH698 LCH183 LCH570 LGB761 LJB020 LJH536 MCJ369 MCJ4472844
Z-2453-2018PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768; KDH099 KDJ422 KDJ564 KEB962 KEE491 KEE541 KKH770 KKJ554 KKJ555 KKJ688 KMB434 KMP958 KPH281 KPP708 KPP709 LBJ626 LCH208 LDH331 LEP836 LGB696 LGP653 LHB978 LHH617 LJE597 LKH051 LMH352 LPJ187 LPJ672 LPP509 MCJ330 MCJ448 MDH289 MCQ53315180
Z-2454-2018PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879; KEB378 KKJ784 MCP374588
Z-2455-2018PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292; LLH858432
Z-2456-2018PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647; LEH169 MCH333300
Z-2457-2018PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688; LCB888 LCH204552
Z-2458-2018PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881; LDP667 LPH861456
Z-2459-2018PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067; KKJ659 LAH044 LEH699 MCH331 MDH290 MCQ5361020
Z-2460-2018PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662; MBJ45448
Z-2461-2018PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746; KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ9934440
Z-2462-2018PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844; KDQ180 KJH311 KKH758 KMP871 KPH811 LAH127 LAH648 LDP694 LHB945 LJE966 LMJ318 LMR835 MAH349 MBE216 MCQ994 MCQ537 MCQ5384968
Z-2463-2018PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995; KJQ124276
Z-2464-2018PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631; LCJ948 MCQ529372
Z-2465-2018PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027; KJQ311 KKE670144
Z-2466-2018PRONOVA SUTURE BLUE 122CM M1.5, D10189; KDQ147 KEJ159 KGH788516
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging

    Look for the product code BV1755 Taper Point 3/8C, D10031 on the packaging.

Where it went and when

Where it was distributed

Distributed in 25 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: yesSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: May 7, 201812. FDA classified it Class II: Jul 17, 201823. Published in FDA’s Enforcement Report: Jul 25, 201834. FDA terminated the recall: Jun 8, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2448-2018 (May 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2448-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA