Ethicon PROCEED Hernia Mesh: Hair Found in Packaging
Ethicon recalls hernia mesh oval (15cm x 20cm) due to hair found in packaging. Consumers should check product codes and contact Ethicon for details.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Ethicon is recalling hernia mesh products because a customer found hair inside the packaging of one unit. This is a packaging issue, not a defect in the mesh itself. Read more at govinfonow.com/recall/64064-ethicon-proceed-hernia-mesh-hair-found-in-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/64064-ethicon-proceed-hernia-mesh-hair-found-in-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0533-2021
Cite this page
“Ethicon PROCEED Hernia Mesh: Hair Found in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64064-ethicon-proceed-hernia-mesh-hair-found-in-packaging. Based on FDA recall #Z-0533-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2021%22&limit=1).
Why it’s dangerous
The hazard is that a hair was found inside the primary packaging of one unit. This could potentially cause a minor issue if the hair enters the surgical site during implantation, but it is not a defect in the mesh itself.
Who’s affected
Patients who received the PROCEED Hernia Mesh Oval (15 cm x 20 cm) from Ethicon. The risk is low as the hair was found in packaging, not in the mesh product.
How to tell if you have this one
Check for the product code PCDG1, lot number PHG118, and GTIN 10705031047716 on the packaging. The expiration date is July 31, 2021.
- Brand
Ethicon- Product
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm- Category
Medical device
What to do — step by step
Check Packaging Details
Look for product code PCDG1, lot number PHG118, and GTIN 10705031047716 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0533-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0533-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.