PlainRecordsBrand recall history
AmniSure International recalls
Every FDA recall record we found for AmniSure International, newest first. Updated Oct. 11, 2026.
1
1 recall since 2008. The most recent was on Jan. 19, 2008.
- Last 12 months
- 0
- Most recent
- 2008-01
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2012–2026121314151617181920212223242526
Class I (FDA, most serious)Other recalls
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1- Jan. 19, 2008AmniSure ROM Test… Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
No recalls match.
How we match: a recall is listed here when the agency names AmniSure International as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.