Lower risk Medical device recall · FDA · Published October 5, 2018

Parietex Composite Parastomal Mesh Recall: Risk of Hernia Recurrence After Surgery

Covidien recalls Parietex composite parastomal mesh (PCOPM15/20) due to reported hernia recurrence after surgery. Patients should monitor for discomfort or bulging and consult their healthcare provider.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0461-2019Medical device Parietex ›

Lower-risk recall

The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.

Take action

Contact the company

Recalling firmCovidien LLC60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

Covidien is recalling Parietex Composite Parastomal Mesh (PCOPM15 and PCOPM20) because it has failed in some patients years after hernia repair, causing hernia recurrence. This may require additional surgery and can cause discomfort or bulging. Read more at govinfonow.com/recall/69666-parietex-composite-parastomal-mesh-recall-risk-of-hernia-recurrence-after.

Source Summary by GovInfoNow · govinfonow.com/recall/69666-parietex-composite-parastomal-mesh-recall-risk-of-hernia-recurrence-after · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0461-2019

Cite this page

“Parietex Composite Parastomal Mesh Recall: Risk of Hernia Recurrence After Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69666-parietex-composite-parastomal-mesh-recall-risk-of-hernia-recurrence-after. Based on FDA recall #Z-0461-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0461-2019%22&limit=1).

The FDA announced on 2018-10-05 that Covidien LLC is recalling Parietex Composite Parastomal Mesh (Product Numbers PCOPM15 and PCOPM20) due to reports of mesh failure leading to hernia recurrence. The agency classified the recall as Class II.

How to tell if you have it

Brand: Parietex
Product: Parietex Composite Parastomal Mesh
Product Numbers: PCOPM15, PCOPM20
Lots: PNI0064, PNI0065, PNI0402, PNJ0496, PNJ0989, PNJ0990, PNK0641, PNL0037, PNL0039, PNL0631, POA0469X, POA0963X, POB0030X, POB0797X, POC0036X, POC0726X, POD0033X, POD0036X, POD1016X, POE0149X, POE0262X, POE0727X, POF0295X, POF0298X, POG0047X, POH0069X, POH0070X, POI0260X, POI0261X, POI0489X, POJ0418X, POJ0880X, POK0364X, POK0366X, POK0789X, POK0790X, POL0082X, PPA0226X, PPA0227X, PPA0508X, PPA0509X, PPB0779X, PPB0780X, PPC0578X, PPD0409X, PPD0410X, PPE0215X, PPE0509X, PPF0179X, PPF0181X, PPF0836X, PPG0035X, PPG0723X, PPH0355X, PPI0630X, PPI0631X, PPI1144X, PPI1145X, PPJ0234X, PPJ0235X, PPJ0698X, PPK0523X, PPK0524X, PPL0082X, PPL0353X, PQA0483X, PQC0100X, PQC0102X, PQD0395X, PQD0397X, PQE0187X, PQE0802X, PQG0391X, PQG1150X, PQG1152X, PQH0608X, PQH0610X, PQI1246X, PQI1248X, PQJ0971X, PQJ0973X, PQK0314X, PQK0316X, PQL0150X, PQL0479X, PQL0481X, PRA1193X, PRA1195X, PRA1655X, PRA1657X, PRA2444X, PRA2446X, PRB1650X, PRB1652X, PRB2015X, PRB2017X, PRC0392X, PRC0394X, PRC1062X, PRC1064X, PRD0248X, PRD0250X, PRD0547X, PRD0549X, PRD1170X, PRD1172X, PRE0479X, PRE0481X, PRE1319X, PRF0408X, PRF0410X, PRG0382X, PRG1020X, PRG1022X, PRH0323X, PRH0325X, PRI0530X, PRI0531X, PRI1166X, PRI1168X, PRI1409X, PRI1411X, PRJ0480X, PRJ0482X, PRK0758X, PRK0760X, PRK1140X, PRK1142X, PRL0129X, PRL0131X, PRL0528X, PRL0530X, PSA0833X, PSA0835X, PSA1207X, PSA1209X, PSB0936X, PSB0938X, PSC0186X, PSC0188X, PSD0420X, PSD0422X, PSE0906X, PSE0908X, PSF0217X, PSF0219X, PSG0778X, PSG0780X, RQA1121X, PRG0380X
Units affected: 7333

The hazard

According to the FDA, reports indicate that the Parietex Composite Parastomal Mesh failed several years after parastomal hernia repair using the modified Sugarbaker technique. This failure led to hernia recurrence requiring additional surgical treatment. Medtronic has received ten worldwide reports of mesh failure in the last five years.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls include the Covidien EndoFLIP System recall (2026-05-13), the Covidien Mon-a-Therm Stethoscope Recall (2026-04-23), and the Covidien Shiley Disposable Decannulation Plug Recall (2026-04-23). Similar recent recalls of similar products include the Covidien EndoStitch Polysorb Loading Unit Recall (2026-04-15), the Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24), and the Covidien V-Loc 90 Wound Closure Device Recall (2026-06-24).

How to tell if you have this one

The product is labeled as Parietex Composite Parastomal Mesh with product numbers PCOPM15 or PCOPM20. It was sold in specific lots listed in the recall notice.

Brand
Parietex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Monitor for Symptoms
Check for discomfort, bulging, or changes in skin over the surgical area.
Consult Healthcare Provider
Continue regular check-ups with your doctor for signs of hernia recurrence.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution--US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Oct 5, 2018Firm started the recall
Nov 14, 2018FDA classified it Class II
Nov 21, 2018Published in FDA’s Enforcement Report
May 7, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Parietex recalls

Link to this recall

<a href="https://govinfonow.com/recall/69666-parietex-composite-parastomal-mesh-recall-risk-of-hernia-recurrence-after">Parietex Composite Parastomal Mesh Recall: Risk of Hernia Recurrence After Surgery (GovInfoNow)</a>

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-0461-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0461-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.