GE Healthcare — Class II medical device recall Z-2015-2012
Terminated recall by GE Healthcare, LLC, reported 2012-07-25, distributed nationwide. GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure
| Recall number | Z-2015-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-06-12 |
| Classified | 2012-07-16 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CN, DE, DZ, EC, EG, FI, GB, JO, JP, MA, NL, OM, PE, SG, SV, TR, UY, ZA |
| Quantity | 279 |
| Lot numbers | 2016995-001, 2016995-002, 2016995-003, 2016995-004, XXXX2010C, XXXX2010D, XXXX2010E |
Product
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Reason for recall
GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
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-2015-2012. 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.