FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
- Recall number
- Z-1630-2018
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
- Status
- Terminated
- Initiated
- 2018-03-06
- Posted
- not on file
- Terminated
- 2018-07-30
- Reason
- Incorrect gel part number listed in a master manufacturing record
- Root cause
- Manufacturing material removal
- Action
- Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. .
- Quantity
- 766 cases
- Distribution
- US state of RI
- Lot, serial or model codes
- Lot# 1610; 1621; 1639; 1737; 1745
- 510(k) numbers
- ["K101793"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- 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
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