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Action®

ACTION PRODUCTS, INC. · Model OR Table Replacement Pad · UDI-DI 00089904008992

FMP
10
510(k) clearances
232
Adverse events (7 deaths)
4
Recalls
381
Facilities

Description

Action® 3" Original Steris

Recalls

DateFirmReason
2020-06-09EHOB, Inc.QC inspection observed that a portion of the lot may have been contaminated with blood.
2015-12-013M Company - Health Care BusinessProduct mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex
2014-10-10Philips Medical Systems, Inc.Mold on gel filled Gel-E and Squishon products
2014-05-28Childrens Medical VenturesThe gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fu

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.