PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported October 5, 2016

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

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 …

Recall #
Z-2889-2016
Affected scope
396,024 eaches
Initiated
August 1, 2016
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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Ethicon, Inc. recalled ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSIL… - a moderate-severity action.

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSIL… was recalled by Ethicon, Inc. in October 5, 2016. Reason: ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)…. Check the official notice for the remedy. Verify recall #Z-2889-2016 with the FDA Devices before acting.

The recall

Ethicon, Inc. issued this moderate-severity FDA Devices recall-ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)….

Moderate
severity level
Class II
classification
October 5, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2889-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2889-2016) was formally reported on October 5, 2016, with the manufacturer initiating the action on August 1, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ethicon, Inc. is listed as the recalling firm, operating out of Somerville, NJ. Federal records list the affected scope as 396,024 eaches.

The documented reason for this recall is: 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 incorre… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

396,024 eaches

Related Recalls

6

3 from same agency

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2889-2016
Date reported October 5, 2016
Date initiated August 1, 2016
Recalling firm Ethicon, Inc.
Firm location Somerville, NJ
Affected scope 396,024 eaches
Distribution Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2889-2016) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature). Recalled by Ethicon, Inc.. Units affected: 396,024 eaches.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2889-2016.
Where was the recalled product distributed?
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2889-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 5, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.