Ethicon Mersilene Tape Recalled for Incorrect Instructions for Use Insert
Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.
What this means for you
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, but the source text identifies the issue as an incorrect Instructions for Use insert, which aligns with the rubric criterion for minor labeling errors or documentation issues.
Plain-English summary
Ethicon, Inc. is recalling Mersilene Tape, also referred to as Mersilene Polyester Fiber Strip or Mersilene Fiber Ligature. The recall involves 396,024 units distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because a group of Mersilene Tape product codes were supplied with an incorrect Instructions for Use (IFU) insert. The affected product codes include Mersilene RS20, RS21, RS22, RS23, D10076, D10117, D5789, D7164, D8014, D8062, D8113, and D9212. All unexpired lots of these specific codes are included in the recall.
Healthcare providers and facilities should check their inventory for these specific product codes and stop using the affected products. Users should contact Ethicon, Inc. for further instructions on how to handle the recalled items.
The recalled product
- Product
- ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 396,024
Distribution
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
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02