Ethicon Recalls PROCEED Surgical Mesh Due to Foreign Material in Packaging
Ethicon is recalling 15 units of PROCEED Surgical Mesh because a hair was found inside the primary packaging of a sterile device.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a foreign material (hair) in sterile packaging, which is a contamination issue but does not involve high-risk pathogens or structural defects.
Plain-English summary
Ethicon, Inc. is recalling 15 units of PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm. The recall is being conducted because the device is sterile, and a customer reported finding a hair inside the primary packaging of a single unit.
The impacted lot, PHG118, consisted of 295 units distributed to 27 countries worldwide, excluding the United States. Ethicon is specifically recalling the 15 units distributed in South Korea in accordance with requirements from South Korea's Ministry of Food and Drug Safety (MFDS). The product code is PCDG1, the GTIN is 10705031047716, and the expiration date is 07/31/2021.
Healthcare providers and patients who have used or possess this specific lot of PROCEED Surgical Mesh should contact Ethicon, Inc. for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Mesh
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
Same hazard · foreign material
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- ModerateSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk Recalled for Foreign Material
FDA (Food) · 2026-09-30
- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Similar recalls
- HighEthicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise
FDA (Devices) · 2014-04-09
- ModerateEXP Recalls PhysioMesh Surgical Mesh Due to Registration Violations
FDA (Devices) · 2015-08-05
- ModerateEXP Recalls PhysioMesh Surgical Mesh Due to Regulatory Non-Compliance
FDA (Devices) · 2015-08-05
- HighEthicon Proline Suture Recall Due to Packaging Perforation Risk
FDA (Devices) · 2018-07-25
- HighEthicon Recalls Prolene Sutures Due to Packaging Perforation Risk
FDA (Devices) · 2018-07-25
- HighEthicon Recalls Proline Sutures Due to Packaging Perforation Risk
FDA (Devices) · 2018-07-25