FDA Medical Device Recalls (openFDA)
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 number
- Z-0455-2007
- Recalling firm
- Embeem Inc.
- 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.
- Status
- Terminated
- Initiated
- 2006-11-09
- Posted
- 2007-01-17
- Terminated
- 2008-07-21
- Reason
- Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
- Root cause
- Other
- Action
- Recall letters were sent out on 11/9/2006 to the retail level
- Quantity
- 1,258 pieces
- Distribution
- There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.
- Lot, serial or model codes
- There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAE
- Firm FEI
- 3005089721
- Firm city
- N Brunswick
- Firm state
- NJ
- 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
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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