Draeger Jaundice Meter JM-105 The device is intended for use in… — Class I medical device recall Z-2047-2018
Terminated recall by Draeger Medical Systems, Inc., reported 2018-06-13, distributed nationwide. Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a z
| Recall number | Z-2047-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Telford, PA, United States |
| Recall initiated | 2018-05-15 |
| Classified | 2018-06-06 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2023-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, UY, VE, VN, ZA |
| Quantity | 6,711 |
Product
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.
Reason for recall
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
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-2047-2018. 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.