Zeiss brand OPMI Pentero C — Class II medical device recall Z-1440-2013
Terminated recall by Carl Zeiss Meditec, Inc., reported 2013-06-12, distributed nationwide. Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system.
| Recall number | Z-1440-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2013-04-18 |
| Classified | 2013-05-31 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2013-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Serial numbers | 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813 |
Product
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Reason for recall
Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.
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-1440-2013. 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.