Codman Certas — Class II medical device recall Z-2186-2014
Terminated recall by Codman & Shurtleff, Inc., reported 2014-08-20, distributed in AL, AZ, CA, CO, CT, DC, DE, FL…. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's In
| Recall number | Z-2186-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2014-07-03 |
| Classified | 2014-08-12 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2017-01-30 |
| Distributed | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HU, IE, IL, IT, KW, LB, LU, NL, NO, PT, RU, SA, SE, SI, TR, ZA |
| Quantity | 9,498 devices |
| Lot numbers | CMBCB2 |
Product
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Reason for recall
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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-2186-2014. 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.