Food, drugs, devices › Ansell Healthcare Products LLC
Device recall: Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Th
Ansell Healthcare Products LLC (Dothan, AL) initiated this device recall on 5 Nov 2012; FDA lists 1 product record under event 63873, classified Class II.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 31 Jul 2013. Initiation: voluntary: firm initiated. Ansell Healthcare Products LLC has 6 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
Ansell Healthcare Products LLC, Dothan, AL.
Reason for recall
"One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn."
Distribution
"Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0717-2013 | Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0. | 445 cases (10680 consumer units) | Class II | Terminated | 30 Jan 2013 |
Context
Other enforcement events for Ansell Healthcare Products LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Aug 2023 | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | Device | Class II | 2 |
| 19 Feb 2022 | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 | Device | Class II | 1 |
| 19 Aug 2020 | MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device in | Device | Class II | 1 |
| 24 Oct 2016 | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, S | Device | Class II | 1 |
| 14 Jan 2013 | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A shea | Device | Class II | 1 |
All 6 events for Ansell Healthcare Products LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn."
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: "Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jul 2013. "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.