ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fi...
FDA Device Recall #Z-2889-2016 — Class II — August 1, 2016
Recall Summary
| Recall Number | Z-2889-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 1, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ethicon, Inc. |
| Location | Somerville, NJ |
| Product Type | Devices |
| Quantity | 396,024 eaches |
Product Description
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Reason for Recall
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
Lot / Code Information
All unexpired lots MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212
Other Recalls from Ethicon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0487-2025 | Class II | MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... | Oct 8, 2024 |
| Z-0319-2025 | Class II | Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... | Sep 25, 2024 |
| Z-2148-2024 | Class II | MONOCRYL (poliglecaprone 25) Suture - Intended ... | May 10, 2024 |
| Z-2144-2024 | Class II | VICRYL (polyglactin 910) Suture - Indicated for... | May 10, 2024 |
| Z-2147-2024 | Class II | PDS Plus Antibacterial (polydioxanone) Suture -... | May 10, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.