FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc.: Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: smith&nephew Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: ***smith&Nephew***#59403125***REMOVE***US Patent no. 5336207***CE***. Formulation F-57 S&N Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. Formulation F-57 S&N Product Code 59403125 REMOVE CE Adhesive Remover. Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. .
- Recall number
- Z-2750-2011
- Recalling firm
- Smith & Nephew Inc.
- Product
- Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: smith&nephew Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: ***smith&Nephew***#59403125***REMOVE***US Patent no. 5336207***CE***. Formulation F-57 S&N Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. Formulation F-57 S&N Product Code 59403125 REMOVE CE Adhesive Remover. Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. .
- Status
- Terminated
- Initiated
- 2011-04-04
- Posted
- 2011-07-06
- Terminated
- 2011-07-18
- Reason
- Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO-STING SKIN-PREP Protective Wipes. These products were manufactured by H&P Industries dba The Triad Group who has initiated a recall of products manufactured i
- Root cause
- Material/Component Contamination
- Action
- Smith & Nephew Inc. sent an "URGENT DEVICE CORRECTION" letter dated April 8, 2011 to all customers who received the recalled products. The letter described the product, problem and the appropriate actions to be taken. Customers are instructed to immediately discontinue using the recalled products, examine their inventory, and follow the return or disposition instructions provided. The letter instructed customers to seek an alternative product for use. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271.
- Quantity
- 299726 Boxes of 50 count
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of: NC, PA, NM, OR, VA, TN, NY, OR, AL, IL, MN, TX, and Puerto Rico and the countries of: Australia, Canada, England, France, Germany, Hong Kong, Japan, Mexico, New Zealand, Singapore, South Africa, Taiwan, and United Kingdom
- Lot, serial or model codes
- UNISOLVE 402300 Lot # 0F195, 0F197, 0F198, 0F223, 0F224, 0F228, 0F229, 0F239, 0H185, 0H226, 0H228, 0H229, 0K207, 0K208, 0K209, 0K233, 0K234, 0M136, 0M137, 0M151, 0M238, 1A103, 1B129, 1B130, 1B131, 1B132. REMOVE CE 59403125: 0E219, 0E226, 0F242, 0G116, 0H256, 0J233, 0J262, 0J263, 0M178, 0M179, 1A106, 1A181, 1A182, 1A192.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KOX
- Firm FEI
- 3006760724
- Firm city
- Saint Petersburg
- Firm state
- FL
- 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