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.