Food, drugs, devices › Molnlycke Health Care, Inc
Device recall: 7x10" Small Utility Positioner with Cover
FDA enforcement event 78058 is a device recall by Molnlycke Health Care, Inc of Norcross, GA, initiated 26 Jul 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Apr 2021. Initiation: voluntary: firm initiated. Molnlycke Health Care, Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Molnlycke Health Care, Inc, Norcross, GA.
Reason for recall
"Products may not meet specifications due to possible presence of metal shavings."
Distribution
"Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0416-2018 | 7x10" Small Utility Positioner with Cover | 960 units total | Class II | Terminated | 7 Feb 2018 |
| Z-0417-2018 | 9x15" Medium Utility Positioner with Cover | 204 units total | Class II | Terminated | 7 Feb 2018 |
Context
Other enforcement events for Molnlycke Health Care, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Mar 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. | Device | Class II | 1 |
| 24 Apr 2017 | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' | Device | Class II | 1 |
All 3 events for Molnlycke Health Care, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Products may not meet specifications due to possible presence of metal shavings."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.