RegWardenFDA facility compliance records
Recall

Class II — Baxter Healthcare Corporation

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
ProductEASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Quantity4,752 units
DistributionUnited States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
Initiated2021-06-15
Classified2021-07-09
Terminated2024-01-12
Recall numberZ-2051-2021
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 — Baxter Healthcare Corporation (Z-2051-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88074/

Not open yet

Alerts for BAXTER HEALTHCARE CORPORATION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.