Device recall: PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

Class II FDA enforcement event 80306. Recall start date: 7 May 2018. Status in the FDA record: Terminated. Termination date: 8 Jun 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Ethicon, Inc. started this device recall on 7 May 2018. The firm address in the FDA record is in Somerville, NJ. FDA put the recall in Class II. FDA event 80306 has 19 product records. The first FDA enforcement report date is 25 Jul 2018. The record gives the status Terminated, with the termination date 8 Jun 2020.

FDA enforcement report The 19 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.

Recalling firm

Ethicon, Inc., Somerville, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

19 product records in the event.

FDA event 80306: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2448-2018	PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031	1752	Class II	Terminated	25 Jul 2018
Z-2449-2018	PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981	1728	Class II	Terminated	25 Jul 2018
Z-2450-2018	PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988	4452	Class II	Terminated	25 Jul 2018
Z-2451-2018	PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416	3024	Class II	Terminated	25 Jul 2018
Z-2452-2018	PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748	2844	Class II	Terminated	25 Jul 2018
Z-2453-2018	PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768	15180	Class II	Terminated	25 Jul 2018
Z-2454-2018	PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879	588	Class II	Terminated	25 Jul 2018
Z-2455-2018	PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292	432	Class II	Terminated	25 Jul 2018
Z-2456-2018	PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647	300	Class II	Terminated	25 Jul 2018
Z-2457-2018	PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688	552	Class II	Terminated	25 Jul 2018
Z-2458-2018	PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881	456	Class II	Terminated	25 Jul 2018
Z-2459-2018	PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067	1020	Class II	Terminated	25 Jul 2018
Z-2460-2018	PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662	48	Class II	Terminated	25 Jul 2018
Z-2461-2018	PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746	4440	Class II	Terminated	25 Jul 2018
Z-2462-2018	PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844	4968	Class II	Terminated	25 Jul 2018
Z-2463-2018	PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995	276	Class II	Terminated	25 Jul 2018
Z-2464-2018	PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631	372	Class II	Terminated	25 Jul 2018
Z-2465-2018	PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027	144	Class II	Terminated	25 Jul 2018
Z-2466-2018	PRONOVA SUTURE BLUE 122CM M1.5, D10189	516	Class II	Terminated	25 Jul 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 19Median of the firm: 1
Events of the firm on the register: 36

Other events of the firm

Other FDA enforcement events of Ethicon, Inc.
Initiated	Product (first record)	Type	Class	Records
8 Oct 2024	MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximat	Device	Class II	1
25 Sep 2024	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H	Device	Class II	1
10 May 2024	VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use	Device	Class II	6
23 Apr 2024	SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.	Device	Class II	1
8 Mar 2024	STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I	Device	Class II	1
31 Mar 2023	PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in	Device	Class II	1
16 Nov 2022	PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximat	Device	Class II	1
20 Sep 2022	STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of	Device	Class II	1
8 Aug 2022	PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles	Device	Class II	1
24 Mar 2022	STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A P	Device	Class II	1

Ethicon, Inc.: all 36 events

Official channels

FDA enforcement report Z-2448-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 80306. https://recallregister.com/fda/ii/80306/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.
What quantity of product is in FDA event 80306?: The event has 19 product records. The first record gives this quantity: 1752
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.