Device recall: VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including…

Class II FDA enforcement event 94643. Recall start date: 10 May 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

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 10 May 2024. The firm address in the FDA record is in Raritan, NJ. FDA put the recall in Class II. FDA event 94643 has 6 product records. The first FDA enforcement report date is 26 Jun 2024. The record gives the status Ongoing.

FDA enforcement report The 6 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.

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Recalling firm

Ethicon, Inc., Raritan, NJ.

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

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

Products

6 product records in the event.

FDA event 94643: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2144-2024	VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H…	341532 units	Class II	Ongoing	26 Jun 2024
Z-2145-2024	VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H	55296 units	Class II	Ongoing	26 Jun 2024
Z-2146-2024	PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is…	56952 units	Class II	Ongoing	26 Jun 2024
Z-2147-2024	PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six…	45828 units	Class II	Ongoing	26 Jun 2024
Z-2148-2024	MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H	306000 units	Class II	Ongoing	26 Jun 2024
Z-2149-2024	MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14…	287892 units	Class II	Ongoing	26 Jun 2024

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 2024: 970
Share of these events in Class II: 87%
Product records in this event: 6Median 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
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
4 Jan 2021	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of	Device	Class II	1

Ethicon, Inc.: all 36 events

Official channels

FDA enforcement report Z-2144-2024The 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 94643. https://recallregister.com/fda/ii/94643/. 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: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
What quantity of product is in FDA event 94643?: The event has 6 product records. The first record gives this quantity: 341532 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.