Condom
FDA adverse event reports and recall history for condom (product code HIS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 405
- Deaths
- 3
- Injuries
- 155
- Malfunctions
- 91
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-27Open, ClassifiedStorage
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
Potential exposure of rodents and rodent activity in the distribution center.
- 2022-08-17Open, ClassifiedStorage
LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2013-02-20TerminatedDevice Design
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).
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.
- 2013-01-24TerminatedPackaging
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.
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
- 2007-12-11TerminatedProcess control
Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA
Condoms fail the water leak test and package integrity
- 2002-12-31TerminatedOther
Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
- TerminatedError in labeling
Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
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