Skip to content

Molnlycke Health Care, Inc.

Also registered as Molnlycke Health Care

United StatesFDA applicant, unverified FDA

Devices
18
Registrations
FDA
FDA recalls
60 ongoing since 2021 (1 open in total)
1 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Molnlycke Health Care, Inc. makes

Molnlycke Health Care, Inc. manufactures wound care dressings, including absorbent film dressings, non-adherent silicone dressings, and saline-based gels for hydration or debridement. Their portfolio also includes surgical drapes and gowns designed for patient and staff protection during procedures, as well as reinforced and standard surgical barriers.

The company’s products are regulated under FDA classifications, including Class I, Class II, and Unclassified (U) devices, with many authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) registry, reflecting their compliance with US medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

Newest first, rows 1-18 of 18

Search and filter all 18 devices
Skip device list

Rows 1-18 of 18

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 3
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

2 initiated before 2017

  • 2019

    • 26 Mar 2019 Z-1243-2019 Class II Terminated Intermittent heat seal failures on the outer pouch of some EZ Derm products.via FDA establishment Molnlycke Health Care AB Distribution: Worldwide Distribution - US Nationwide distribution to AL, AZ, CA, CO, DC, FL, GA, IA, IL, KS, LA, MA, MD, MN, MO, NC,…
      Full distribution text Worldwide Distribution - US Nationwide distribution to AL, AZ, CA, CO, DC, FL, GA, IA, IL, KS, LA, MA, MD, MN, MO, NC, NE, NJ, OK, PA, RI, TN, TX, VA, WA, WI. International distribution to Chile, Jamaica.
      Submission number: K935189

  • 2017

    • 26 Jul 2017 Z-0416-2018 Class II Terminated Products may not meet specifications due to possible presence of metal shavings.via FDA establishment Molnlycke Health Care AB Distribution: Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
    • 26 Jul 2017 Z-0417-2018 Class II Terminated Products may not meet specifications due to possible presence of metal shavings.via FDA establishment Molnlycke Health Care AB Distribution: Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
    • 24 Apr 2017 Z-2110-2017 Class II Open since 2017 Sterilization validation failure.via FDA establishment Molnlycke Health Care AB Distribution: Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France,…
      Full distribution text 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.

  • 2007

    • 20 Jul 2007 Z-1219-2007 Unclassified (pre-2012) Terminated Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.via FDA establishment Molnlycke Health Care AB Distribution: Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI

  • 2003

    • 14 Jul 2003 Z-1137-03 Unclassified (pre-2012) Terminated pouch may tear which could result in contamination of sterile fieldvia FDA establishment Molnlycke Health Care AB Distribution: The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped…
      Full distribution text The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.
      Submission number: K780282

FDA establishments3

Registered with the FDA under this company group, matched by name.

  • Molnlycke Health Care OLDHAM · GB Other ID 2819
  • Molnlycke Health Care AB Molndal Vastra Gotaland · SE FEI 3007048057
  • Molnlycke Health Care Oy Mikkeli Etela-Savo · FI FEI 3007605720

Frequently asked questions

How many devices does Molnlycke Health Care, Inc. have in the registry?

The registry currently lists 18 devices for Molnlycke Health Care, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Molnlycke Health Care, Inc.'s devices?

Among its 18 most recently registered devices, Molnlycke Health Care, Inc. has devices listed in FDA 510(k) (18 devices).

What risk classes do Molnlycke Health Care, Inc.'s devices fall under?

Among its 18 most recently registered devices, the classes recorded for Molnlycke Health Care, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Molnlycke Health Care, Inc.?

FDA recall records list 6 recalls initiated by Molnlycke Health Care, Inc., the most recent initiated on 26 Mar 2019. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Molnlycke Health Care, Inc. in the registry?

The most recently registered devices listed for Molnlycke Health Care, Inc. include AVANCE® FOAM ABDOMINAL DRESSING KIT, ALLDRESS, ABSORBENT FILM DRESSING, AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM and BARRIER SURGICAL GOWNS.

Which FDA establishments are linked to Molnlycke Health Care, Inc.?

3 FDA establishments are linked to Molnlycke Health Care, Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.