FDA Medical Device Recalls (openFDA)
Lumitex Inc: Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.
- Recall number
- Z-1998-2009
- Recalling firm
- Lumitex Inc
- Product
- Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.
- Status
- Terminated
- Initiated
- 2009-07-01
- Posted
- 2009-09-03
- Terminated
- 2012-03-09
- Reason
- Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.
- Root cause
- Nonconforming Material/Component
- Action
- Lumitex, Inc. issued a recall letter dated July 2, 2009 to their Customers describing the affected device and requesting its return. For further information, contact Lumitex, Inc. at 1-440-243-8401.
- Quantity
- 59 packs/5 individual units
- Distribution
- Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
- Lot, serial or model codes
- Model Number: UA2550; Lot Number: I01161.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDG
- Firm FEI
- 1000122810
- Firm city
- Strongsville
- Firm state
- OH
- 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