CLASS II ONGOING Device recall · Reported 24 May 2017 · FDA Enforcement Report

Brennen Skin Graft Mesher recalled by Molnlycke Health Care

Molnlycke Health Care is recalling Brennen Skin Graft Mesher, distributed nationwide in the US. The recall was initiated on 24 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.

Quantity recalled956 units

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-2110-2017
FDA event ID: 77121
Recalling firm: Molnlycke Health Care, Norcross, GA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Apr 2017
FDA classified: 18 May 2017
Reported: 24 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

24 Apr 2017	Recall initiated by company
18 May 2017	Classified by FDA	+24 days
24 May 2017	Published in enforcement report	+6 days

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

Reason for recall

Sterilization validation failure.

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

Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

Where it was distributed

Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.

Nationwide

Questions about this recall

Why was it recalled?

Sterilization validation failure.

Which lots are affected?

Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.

Where was it sold?

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.

More recalls from Molnlycke Health Care

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7 Feb 2018Device	CLASS II	" Medium Utility Positioner with Cover recalled by Molnlycke Health Care	Molnlycke Health Care	Foreign Material	17 states

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