Has Stryker Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 89 total FDA actions tied to Stryker Corporation: 0 warning letters, 89 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 2023-04-12; 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.

.hq

fda_recall · device_recall · high

Stryker Corporation — Class II recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PR…

Name: FDA Recall Record — Stryker Corporation
Creator: Argus HQ
Published: 2023-04-12
License: https://argushq.ai/methodology

Event date: 2023-04-12 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1344-2023
Payload hash: 04d6dfc05631aba0a6f7d180…

Summary

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications Status: Ongoing.

Entities

Stryker Corporation

View source record ↗

Frequently asked questions

Has Stryker Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 89 total FDA actions tied to Stryker Corporation: 0 warning letters, 89 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 2023-04-12; 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 Corporation — Class II recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PR…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-corporation-z-1344-2023

MLA

"Stryker Corporation — Class II recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PR…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-stryker-corporation-z-1344-2023.

Chicago

Argus HQ Research. "Stryker Corporation — Class II recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PR…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-corporation-z-1344-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_stryker_corporation_z_1344_2023_2023,
  title = {Stryker Corporation — Class II recall: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PR…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-corporation-z-1344-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.