ANDOVER HEALTHCARE, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (1)
- Bandage, CastProduct code ITG (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3025
Recalls & enforcement
- Class IIOngoing2024-04-02A packaging seal gap could impact the sterility of the product.
- Class IITerminated2019-06-19Incomplete packaging seal of sterile product
FDA inspections (1)
- NAI2017-02-22No Action Indicated · Compliance: Devices
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. “ANDOVER HEALTHCARE, INC. (FEI 1220799) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220799-andover-healthcare-inc/
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