PlainRecordsBrand recall history
Stradis Healthcare recalls
Every FDA recall record we found for Stradis Healthcare, newest first. Updated Oct. 11, 2026.
9
9 recalls since 2015. The most recent was on Jan. 18, 2023.
- Last 12 months
- 0
- Most recent
- 2023-01
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2015–2026151617181920212223242526
Class I (FDA, most serious)Other recalls
All recalls
9- Jan. 18, 2023Stradis Healthcare Foley Catheter Insertion Tray with preconnected… and 17 more products Class IIPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Dec. 21, 2022Stradis Healthcare… and 77 more products Class IIMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed…
- Sept. 14, 2022VYGON DRESSING CHANGE W/MAXISWAB kit… Class IIPotential for incomplete seals.
- Aug. 24, 2022NARMD MEDICAL DEPOT Scissors Iris Curved 4.5"… and 2 more products Class IIThe sterile barrier may be compromised.
- June 1, 2022Surgical Suture Kit Class IIThere is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
- April 13, 2022Surgicare Neuro Pack… and 4 more products Class IIThe outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
- Dec. 29, 2021Custom Assemblies… Class IIThis recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders…
- Oct. 27, 2021Tenaculum… and 5 more products Class IIFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- July 15, 2015Breast Pack… and 50 more products Class IIConvenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
No recalls match.
How we match: a recall is listed here when the agency names Stradis Healthcare as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.