RegWardenFDA facility compliance records
Recall

Class II — Andover Healthcare Inc.

Recalling firmANDOVER HEALTHCARE, INC.
Registered facilityANDOVER HEALTHCARE, INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonA packaging seal gap could impact the sterility of the product.
ProductSterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Quantity108 cases (1,944 individual product packages)
DistributionUS Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
Initiated2024-04-02
Classified2024-05-15
Recall numberZ-1828-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Andover Healthcare Inc. (Z-1828-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94394/

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