Intrinsic Therapeutics, Inc.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (4)
Devices registered here (1)
- Reherniation Reduction DeviceProduct code QES (opens in a new tab) · Class III · Unknown
Recalls & enforcement
- Class IIOngoing2024-07-25At least two units have been found to be missing a weld.
- Class IITerminated2020-07-24The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.
FDA inspections (4)
- NAI2025-09-26No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2022-07-21Voluntary Action Indicated · Compliance: Devices · citations posted
- NAI2017-09-29No Action Indicated · Compliance: Devices
- NAI2017-03-31No Action Indicated · Bioresearch Monitoring
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Intrinsic Therapeutics, Inc. (FEI 3006232063) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006232063-intrinsic-therapeutics-inc/
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