Surgical Mesh Recalled Due to Incorrect Collagen Film Placement
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with potential for serious complications including adhesions, fistula, and implant failure. However, no illnesses or injuries have been reported in the source text, and the hazard is stated as theoretical ('may cause'). Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' qualifying as High (Score 3).
Plain-English summary
Covidien, LP is recalling a specific lot (PVE0194M) of Parietex Composite Mesh Polyester with Absorbable Collagen Film, horseshoe-shaped (9 x 8 cm / 3.6" x 3.1"), Model Number PCO2H3. This surgical mesh is intended for reinforcement of tissues during surgical repair.
The recalled product has the collagen film positioned on the opposite side of the mesh. This incorrect placement may cause delays to treatment and therapy, adhesions, erosion or migration of the implant, pain, fistula formation, hernia recurrence, and failure of the implant.
A total of 53 units were distributed in the United States to California, Georgia, and New York, with additional distribution to Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland, and the United Kingdom. Healthcare facilities and patients who have received this recalled product should contact Covidien for further guidance.
The recalled product
- Product
- Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Surgical Mesh
- Hazard
- treatment-delay
- adhesions
- erosion
- migration
- pain
- fistula
- hernia-recurrence
- implant-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: A8845211784602 Lot Number: PVE0194M
Distribution
Distributed in 3 states:
- CA
- GA
- NY
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