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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.

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.