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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

5 recalls · page 1 of 1

Medical devices

Reported Dec 21, 2022

STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stradis Medical, LLC dba Stradis Healthcare

Matched: Brand · Product · Product details · Reason for recall — Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed,…

77 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 24, 2022

NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stradis Medical, LLC dba Stradis Healthcare

Matched: Brand · Product · Product details — The sterile barrier may be compromised.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 13, 2022

Surgicare Neuro Pack - Neurological Kit

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stradis Medical, LLC dba Stradis Healthcare

Matched: Brand — The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 29, 2021

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stradis Medical, LLC dba Stradis Healthcare

Matched: Brand — This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders…

FDA (openFDA device enforcement)

Medical devices

Reported Oct 27, 2021

Tenaculum, Plastic

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stradis Medical, LLC dba Stradis Healthcare

Matched: Brand — Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

5 more products in this recall

FDA (openFDA device enforcement)

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