RecallRadar

FDA Device recall Z-0533-2021

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

On 2020-12-09 the FDA classified a Class II recall of PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm by Ethicon, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0533-2021
ClassificationClass II
Statusterminated
Initiated2020-10-23
Published2020-12-09
Last updated2026-09-13 11:55 UTC
CompanyEthicon
Distributionn/a

Product

PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Reason

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.

Identifiers

code_infoProduct Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.