Z-1848-2019Class II

Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1

Name: Z-1848-2019 Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Creator: Stryker GmbH
Published: 2019-04-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-04-30 / Terminated / root cause: packaging

FDA source

Stryker GmbH began a recall of Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 on 2019-04-30. FDA classified it as Class II and gives the reason as "The seal integrity of the sterile bag containing the kits may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1848-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-30
Posted: 2019-06-20
Terminated: 2020-09-18
Recalling firm: Stryker Corp.
Product: Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Product code: HRX Arthroscope
Reason for recall: The seal integrity of the sterile bag containing the kits may be compromised.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
Quantity in commerce: 447
Distribution: The products were distributed US nationwide.
Product codes and lots: Lot # 01410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1848-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-20
Z-1849-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-20

Product code HRX

K922391Class IIEndoscopic Carpal Tunnel InstrumentsInstratek, Inc. / cleared 1992-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)