fda_recall · device_recall · high
Stryker Sustainability Solutions — Class II recall: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921…
- Event date
- 2023-04-05 00:00:00Z
- Observed
- 2026-07-16 23:20:09Z
- Source ID
- Z-1315-2023
- Payload hash
- bdedf55bb0508d681c981e8b…
Summary
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vas… Status: Ongoing.
Entities
Frequently asked questions
- Has Stryker Sustainability Solutions had other FDA enforcement actions?
- Yes. Argus HQ has recorded 34 total FDA actions tied to Stryker Sustainability Solutions: 0 warning letters, 34 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What kind of FDA record is this?
- This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-04-05; Argus observed and indexed it on 2026-07-16.
- Where can I verify this record directly with FDA?
- The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
APA
Argus HQ Research (2023). Stryker Sustainability Solutions — Class II recall: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-sustainability-solutions-z-1315-2023
MLA
"Stryker Sustainability Solutions — Class II recall: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-stryker-sustainability-solutions-z-1315-2023.
Chicago
Argus HQ Research. "Stryker Sustainability Solutions — Class II recall: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-sustainability-solutions-z-1315-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_stryker_sustainability_solutions_z_1315_2023_2023,
title = {Stryker Sustainability Solutions — Class II recall: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921…},
author = {{Argus HQ Research}},
year = {2023},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/events/fda-recall-stryker-sustainability-solutions-z-1315-2023},
note = {Accessed: July 23, 2026}
}Informational only. Not legal, financial, or medical advice.

