Embeem Inc. HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.
Brand
Embeem Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
Embeem Inc. is recalling HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. P due to Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
Recommended Action
Per FDA guidance
Recall letters were sent out on 11/9/2006 to the retail level
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026