RegWardenFDA facility compliance records
Recall

Class II — Steris Corporation

Recalling firmSTERIS Corporation
Registered facilityKey Surgical, LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
ProductDual Articulating Headrest, Velcro P/N P141210813, REF BF753
Quantity80
DistributionWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.
Initiated2023-12-12
Classified2024-02-05
Recall numberZ-0984-2024
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 — Steris Corporation (Z-0984-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93733/

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