CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Mynxgrip 5F recalled by Cordis US
Cordis US is recalling Mynxgrip 5F, distributed in 7 states. The recall was initiated on 28 Nov 2023 and the FDA has classified it as Class II.
Check your package
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-0674-2024
- FDA event ID
- 93617
- Recalling firm
- Cordis US, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 28 Nov 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +38 days |
| 17 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Where it was distributed
US: NC, WV, TN, MS, MI, OH, CA
CaliforniaMichiganMississippiNorth CarolinaOhioTennesseeWest Virginia
Questions about this recall
Why was it recalled?
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Which lots are affected?
UDI/DI 10862028000403, Lot numbers: F2322902
Where was it sold?
US: NC, WV, TN, MS, MI, OH, CA
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
1 other product · FDA event 93617| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mynxgrip 6f/7f recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
More recalls from Cordis US
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cordis, REF: C09060ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Cordis, REF C10040ML, Smart Control Vascular Stent System recalled | Cordis US | Packaging Defects | 5 states |
| Device | CLASS II | Vista Brite Tip, Judkins Right recalled by Cordis US | Cordis US | Other | WA |
| Device | CLASS II | Mynxgrip 6f/7f recalled by Cordis US | Cordis US | Packaging Defects | 7 states |
| Device | CLASS I | Cordis Angiographic Catheterization Sets, Infiniti Thrulemen, 5F recalled | Cordis US | Sterility | OK |
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |