EZ Derm Porcine Xenograft — Class II medical device recall Z-1243-2019
Terminated recall by Molnlycke Health Care, Inc, reported 2019-05-08, distributed nationwide. Intermittent heat seal failures on the outer pouch of some EZ Derm products.
| Recall number | Z-1243-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Molnlycke Health Care, Inc, Norcross, GA, United States |
| Recall initiated | 2019-03-26 |
| Classified | 2019-04-30 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2021-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, JM |
| Quantity | 1,332 units |
| Reason classes | packaging |
| Lot numbers | 18409555, 18409557, 18409559, 18409561, 18409562, 18411790, 18411791, 18411792, 18411793, 18411794, 18418738, 18418739, 18418740, 18421331, 18421332, 18421333, 18421334, 18421375, 18421376, 18421377, 18421378, 18429844, 18429855, 18435025, 18435026, 18435028, 18435029, 18435030, 18435031, 18435032, 18435885, 18435886, 18448582, 18448583, 18448584, 18448595, 18448596, 18448597, 18448598, 18448599 and 93 more |
| Model numbers | 131703-03, 131704-03, 131705-03, 131710-03, 131711-03, 131712-03, 131713-03, 131714-03, 131715-03 |
Product
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
Reason for recall
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
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-1243-2019. 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.