Device recall: PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Class II FDA enforcement event 86631. Recall start date: 23 Oct 2020. Status in the FDA record: Terminated. Termination date: 21 Dec 2022.

Reason for recall, in the words of FDA

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

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 23 Oct 2020. The firm address in the FDA record is in Somerville, NJ. FDA put the recall in Class II. FDA event 86631 has 1 product record. The first FDA enforcement report date is 9 Dec 2020. The record gives the status Terminated, with the termination date 21 Dec 2022.

FDA enforcement report The 1 product record

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.

The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's…

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

1 product record in the event.

FDA event 86631: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0533-2021	PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm	295 units distributed. Only 15 units are being recalled.	Class II	Terminated	9 Dec 2020

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 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median 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-0533-2021The 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 86631. https://recallregister.com/fda/ii/86631/. 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: The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's…
What quantity of product is in FDA event 86631?: The FDA record gives this quantity: 295 units distributed. Only 15 units are being recalled.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.