Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-12-26 | Z-1181-2026 | Class II | Open, Classified | Potential exposure of rodents and rodent activity in the distribution center.Distribution: US Nationwide distribution in the states of Minnesota. | unknown | clearance family |
Regulatory clearances
- 510(k)K120249Substantially equivalent (SESE) · 2012-05-11clearance family
Predicate lineage
K895640
Cited as predicate by: K120249
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-12 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2024-07-18 | NAI | No action indicated | Church & Dwight Canada Corp. | 0 |
| 2023-08-08 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2022-07-15 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2017-10-31 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 1 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-03-13 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-08-24 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-02-17 | NAI | No action indicated | Church & Dwight Co., Inc. | 0 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2010-07-08 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 3 |
Similar devices
- "ONE ""Fun Mix" GLOBAL PROTECTION CORP.
- "ONE ""Popular Mix" GLOBAL PROTECTION CORP.
- "ONE ""Sensitive Mix" GLOBAL PROTECTION CORP.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® CONDOMS OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- ADAM & EVE SURETEX LIMITED - BRANCH
Select up to two to place side-by-side with this device.