Recall Register

Food, drugs, devices › Firms

Cordis US Corp

FDA recalling firm · 7 enforcement events · 22 product records · 2022–2025 · FL

Cordis US Corp has 7 FDA enforcement events on this register (22 product records) between 2022 and 2025: 7 device; the busiest year was 2023 with 3.

29% of its events are Class I; the most common class is Class II (5). 7 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
4 Mar 2025Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx OnlyDeviceClass II2Ongoing
7 Feb 2025Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.DeviceClass II1Ongoing
28 Nov 2023MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.DeviceClass II2Ongoing
26 Sep 2023Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheterDeviceClass I1Ongoing
24 Mar 2023ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCDeviceClass I14Ongoing
7 Nov 2022Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.DeviceClass II1Ongoing
20 May 2022PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.DeviceClass II1Ongoing

By type and class

Device7
Class II5
Class I2

Class I: 29% of this firm's events; 18% of all events on the register.

Events by year

22
23
24
25
26
Enforcement events for Cordis US Corp by year initiated.

Questions and answers

How many FDA recalls has Cordis US Corp had?

7 enforcement events (22 product records) on this register, 2022–2025: 7 device.

Are any Cordis US Corp recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are Cordis US Corp recalls?

5 Class II, 2 Class I. 29% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.