CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

Zip 8i Surgical Skin Closure Device recalled by Zipline Medical

Zipline Medical is recalling Zip 8i Surgical Skin Closure Device, distributed nationwide in the US. The recall was initiated on 5 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1002690, Exp 2015-08

Quantity recalled3109 - total - all model numbers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1234-2015
FDA event ID: 70466
Recalling firm: Zipline Medical, Campbell, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2015
FDA classified: 2 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

5 Feb 2015	Recall initiated by company
2 Mar 2015	Classified by FDA	+25 days
11 Mar 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

Nationwide

Questions about this recall

Why was it recalled?

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Which lots are affected?

Lot 1002690, Exp 2015-08

Where was it sold?

Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 70466

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015	CLASS II	Zip 8M Wound Closure Device recalled by Zipline Medical	Zipline Medical	Sterility	Nationwide
11 Mar 2015	CLASS II	Zip 16 Surgical Skin Closure Device recalled by Zipline Medical	Zipline Medical	Sterility	Nationwide

More recalls from Zipline Medical

All 3

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015Device	CLASS II	Zip 16 Surgical Skin Closure Device recalled by Zipline Medical	Zipline Medical	Sterility	Nationwide
11 Mar 2015Device	CLASS II	Zip 8M Wound Closure Device recalled by Zipline Medical	Zipline Medical	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide