Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure — Class II medical device recall Z-1988-2013
Terminated recall by Aspen Surgical Products, Inc., reported 2013-08-28, distributed nationwide. Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indica
| Recall number | Z-1988-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aspen Surgical Products, Inc., Caledonia, MI, United States |
| Recall initiated | 2013-07-18 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, NL |
| Reason classes | sterility |
| Lot numbers | 10425, 10504, 10727, 11178, 11179, 11260, 11261, 11305, 11558, 11731, 11974, 12353, 2014-07, 2014-11, 2014-12, 2015-02, 2015-03, 2015-04, 2015-05, 2015-06, 2015-07, 2015-10, 2015-11, 2015-12, 2016-01, 2016-02, 2016-03, 2016-04, 2016-05, 2016-07, 2016-11, 2016-12, 2017-01, 2017-03, 2017-04, 2017-05, 2017-08, 2017-09, 2017-10, 2017-11 and 55 more |
Product
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
Reason for recall
Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1988-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.