Cordis US Corp

Complete recall history across all FDA and CPSC categories — 22 total recalls

Cordis US Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (22)

FDA medical device enforcement actions by Cordis US Corp

Date Product Reason Class
Mar 4, 2025 Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm ... product mix-up; Vascular stent labeled as one size but contains a different ... Class II
Mar 4, 2025 Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... product mix-up; Vascular stent labeled as one size but contains a different ... Class II
Feb 7, 2025 Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. G... Catheter manufactured at the incorrect length. Class II
Nov 28, 2023 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... Cordis became aware that the label for the carton box containing 10 units is ... Class II
Nov 28, 2023 MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... Cordis became aware that the label for the carton box containing 10 units is ... Class II
Sep 26, 2023 Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... Non-sterile product labeled as sterile was distributed. Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC There is a potential for separation of the ANGIOGUARD RX / XP delivery syste... Class I
Nov 7, 2022 Cordis Angiographic Catheter Extensions. Used to transport fluid from th... There is a potential for separation at the male connector. Class II
May 20, 2022 PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, ... Potential for stent dislodgement and associated failures related to two speci... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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