openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
These labels are deterministic app interpretations, not FDA categories.
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Code information
Serial Numbers Affected: V133AW9885 through V142AW0261and manufactured between May 12, 2020 and May 21, 2020
Distribution pattern
Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
device · product 2 of 2
Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
These labels are deterministic app interpretations, not FDA categories.
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Code information
Serial Numbers Affected: V133PF2502 through V142PF3819 and manufactured between May 12, 2020 and May 21, 2020
Distribution pattern
Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
