Device recall: LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A…
Class II FDA enforcement event 64246. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
Class II, in the words of FDA
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
Ansell Healthcare Products LLC started this device recall on 14 Jan 2013. The firm address in the FDA record is in Iselin, NJ. FDA put the recall in Class II. FDA event 64246 has 1 product record. The first FDA enforcement report date is 27 Feb 2013. The record gives the status Terminated, with the termination date 6 Aug 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
Recalling firm
Ansell Healthcare Products LLC, Iselin, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0838-2013 | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). | 469,134 units | Class II | Terminated | 27 Feb 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| 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 |
| 5 Nov 2012 | Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Th | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0838-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 64246. https://recallregister.com/fda/ii/64246/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
- What quantity of product is in FDA event 64246?
- The FDA record gives this quantity:
469,134 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.