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
StatusTerminated
ReasonIncomplete packaging seal of sterile product
ProductSterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
Quantity269 Cases
DistributionUS Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
Initiated2019-06-19
Classified2019-10-23
Terminated2020-09-09
Recall numberZ-0183-2020
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-0183-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83239/

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