Data Foundry

Medical device recalls 2019

Hudson RCI Sheridan Uncuffed: a) 2 — Class I medical device recall Z-2315-2019

Terminated recall by Teleflex Medical, reported 2019-09-18, distributed nationwide. Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming

Recall numberZ-2315-2019
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Morrisville, NC, United States
Recall initiated2019-07-30
Classified2019-09-09
Reported by FDA2019-09-18
Terminated2022-02-15
DistributedNationwide (US)
Quantity170,740 units
Lot numbers73A1700096, 73A1700097, 73A1700098, 73A1700099, 73A1700100, 73A1700260, 73A1700261, 73A1700262, 73A1700263, 73A1700264, 73A1700725, 73A1800055, 73A1800056, 73A1800057, 73A1800058, 73A1800059, 73A1800060, 73A1800061, 73A1800462, 73A1800463, 73A1800811, 73A1800812, 73B1700143, 73B1700145, 73B1700298, 73B1700299, 73B1700300, 73B1700301, 73B1700389, 73B1700621, 73B1800120, 73B1800121, 73B1800122, 73B1800329, 73B1800346, 73B1800347, 73B1800348, 73B1800349, 73B1800484, 73B1800485 and 181 more
Model numbers5-10404, 5-10405, 5-10406, 5-10407, 5-10408, 5-10409, 5-10410, 5-10411, 5-10412, 5-10413, 5-10414

Product

Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 Product Usage: Tracheal tube/airway management

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

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-2315-2019. 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.