Z-0455-2007

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...

Name: Z-0455-2007 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...
Creator: Embeem Inc.
Published: 2006-11-09
License: https://open.fda.gov/license/

Embeem Inc. / initiated 2006-11-09 / Terminated / root cause: sterility

FDA source

Embeem Inc. began a recall of 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... on 2006-11-09. The reason FDA records is "Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0455-2007
Status: Terminated
Initiated: 2006-11-09
Posted: 2007-01-17
Terminated: 2008-07-21
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.
Product code: NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Reason for recall: Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
Root cause tag: sterility
FDA root cause: Other
Action: Recall letters were sent out on 11/9/2006 to the retail level
Quantity in commerce: 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.
Product codes and lots: There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.

Product code NAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)