CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Stradis Healthcare, Vasc Vein recalled by Stradis Medical

Stradis Medical is recalling Stradis Healthcare, Vasc Vein, distributed nationwide in the US. The recall was initiated on 2 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0541-2023
FDA event ID: 91124
Recalling firm: Stradis Medical, Peachtree Corners, GA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Nov 2022
FDA classified: 14 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

2 Nov 2022	Recall initiated by company
14 Dec 2022	Classified by FDA	+42 days
21 Dec 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,

Where it was distributed

US nationwide distribution, and Canada.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038

Where was it sold?

US nationwide distribution, and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

77 other products · FDA event 91124

This product is part of a recall event; the main page for the event is Henry Schein, Vas Reversal Pack recalled by Stradis Medical.

Reported	Class	Recall	Company	Reason	Where
21 Dec 2022	CLASS II	Henry Schein, Vas Reversal Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Angioplasty recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surg Pk recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Single Shot Epidural recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Venous Access Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Surgical Pain Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Loop Recorder Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surgery PK recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Basin Set recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Basic Pack kits recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Novasure Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Universal Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Curved Tip Syringe recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Procedure Kit recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Vas Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Phleb recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Labiaplasty PackItem No.570 recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Pacemaker Pack IItem No.570 recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Surgical room, Implant Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Basic Implant Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surg Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Major Extremity Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	www.StradisHealthcare.com, Endovenous Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Extremity Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Endo Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surg recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Basic Extended Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Phlebectomy Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Cath Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Omfs recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Vein recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Vein & Laser recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Blue Tail Custom Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Vein recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Femoral, Vasc recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Vein Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Angio Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Lipo recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Ent Set Up Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Vein Clinics recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Rhino Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Introducer Kit Micro recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Amnio Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Basic Implant Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Surgical room, Surgical Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Cath Angio Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Knee Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Temp Stimulator Supplies recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Varicosity Basic Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Bone Marrow Kit recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Breast recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	ACE Surgical Supply, 17539 Custom Kit Sterile recalled	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Medical Vein recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Cotton Applicator 3" recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Procedure Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Basin Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surgical Pk recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Implants recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Ent Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Breast Augmentation tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Weckcell Eye Spears recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Perio Surgery recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Tip, Surge-o-vac .125" Green recalled	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Surgical Pk recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Dental Custom Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Thoracic Phleb recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Gyn Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Vein RF Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Ablation Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Custom PK recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Surgical room, Dental Surgical Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Probe Cover W/gel Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Safety Pins, Small 1" recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Stradis Healthcare, Custom Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Breast Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022	CLASS II	Henry Schein, Ilr Insertion Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide

More recalls from Stradis Medical

All 93

Reported	Class	Recall	Company	Reason	Where
21 Dec 2022Device	CLASS II	Henry Schein, Ilr Insertion Tray recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022Device	CLASS II	Henry Schein, Breast Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022Device	CLASS II	Stradis Healthcare, Custom Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022Device	CLASS II	Stradis Healthcare, Safety Pins, Small 1" recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide
21 Dec 2022Device	CLASS II	Stradis Healthcare, Probe Cover W/gel Pack recalled by Stradis Medical	Stradis Medical	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide