PenBlade Safety Scalpel — Class II medical device recall Z-2800-2015
Terminated recall by Zien Medical Technologies, Inc, reported 2015-09-30, distributed nationwide. Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of
| Recall number | Z-2800-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zien Medical Technologies, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2015-08-18 |
| Classified | 2015-09-21 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2015-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB |
| Quantity | 28,284 |
| Reason classes | sterility, packaging |
| Lot numbers | 140901J-A, 140901J-B, 140901J-C, 150226PB15, 150227PB11, 150228PB10, 150318PB11, 150326PB15, 150509PB10, 150509PB11, 150510PB10, 150510PB11, 150511PB15, 150512PB15, 150529PB15 |
| Model numbers | PB-M-10, PB-M-11P, PB-M-15 |
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
Reason for recall
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.
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-2800-2015. 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.