FDA Device recall Z-2242-2015
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm by Exp Pharmaceutical Services, citing EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2242-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-11 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Exp Pharmaceutical Services |
| Distribution | AR, CA, CO, DC, FL, TX |
Product
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Reason
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Identifiers
| code_info | OEM Catalog number PHY1015V. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2242-2015%22
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