Recall archive
9 recalls · page 1 of 1
Reported Jan 18, 2023
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare
Matched: Brand · Product · Product details — Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
17 more products in this recall
FDA (openFDA device enforcement)
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 — 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)
Reported Sep 14, 2022
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare
Matched: Brand — Potential for incomplete seals.
FDA (openFDA device enforcement)
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 — The sterile barrier may be compromised.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
Surgical Suture Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare
Matched: Brand — There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
FDA (openFDA device enforcement)
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)
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)
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)
Reported Jul 15, 2015
Breast Pack - contains Devon Light Glove Used during surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Healthcare, LLC.
Matched: Brand — Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
50 more products in this recall
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up