FDA Device recall Z-1329-2014
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias…
- FDA Device
- Class II
- ongoing
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias… by Ethicon, citing the possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1329-2014 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2014-02-19 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon |
| Distribution | AL, CA, FL, GA, ID, IL, LA, MA, MO, MS, NC, NJ, OK, PA, TN, TX, UT, WA, WV |
Product
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Reason
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Identifiers
| code_info | Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1329-2014%22
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