Class II — Zien Medical Technologies, Inc
| Recalling firm | Zien Medical Technologies LLC |
|---|---|
| Registered facility | ZIEN MEDICAL TECHNOLOGIES LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product. |
| Product | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 |
| Quantity | 28,284 |
| Distribution | Worldwide distribution to U.S. nationwide, Germany and England. |
| Initiated | 2015-08-18 |
| Classified | 2015-09-21 |
| Terminated | 2015-12-09 |
| Recall number | Z-2800-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zien Medical Technologies, Inc (Z-2800-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72038/
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