FDA Medical Device Recalls (openFDA)
Action Products Incorporated: Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
- Recall number
- Z-2236-2009
- Recalling firm
- Action Products Incorporated
- Product
- Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
- Status
- Terminated
- Initiated
- 2009-06-26
- Posted
- 2009-09-22
- Terminated
- 2009-09-29
- Reason
- Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.
- Root cause
- Process control
- Action
- Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.
- Quantity
- 1 carton
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- I1PSX-0000
- 510(k) numbers
- ["K811528"]
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 1181047
- Firm city
- Hagerstown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28