The FDA has posted 5 enforcement recalls from Healthmark Industries Co., Inc. since 2025, none of them Class I (most serious). Most recent report: Sep 2, 2026.
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Product does not have FDA clearance.
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation.…
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation.…
Firm name as filed with the FDA: “Healthmark Industries Co., Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.