Data Foundry

Medical device recalls 2019

RESERVOIR "Y" ADAPTER — Class II medical device recall Z-0785-2019

Ongoing recall by Medtronic Perfusion Systems, reported 2019-02-06, distributed nationwide. Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracki

Recall numberZ-0785-2019
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Perfusion Systems, Brooklyn Park, MN, United States
Recall initiated2018-11-27
Classified2019-01-29
Reported by FDA2019-02-06
DistributedNationwide (US)
Countries outside the USAU, CA, DE, FR, JP, SE
Quantity1,100 units
Reason classespackaging
UPC / GTIN / UDI-DI10673978522460, 10673978522477
Serial numbers10673978522460, 10673978522477, 215782209, 215903433, 216034158, 216044420, 216062719, 216107790, 216372963, 216438180, 216438301, BT926

Product

RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.

Reason for recall

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

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-0785-2019. 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.