CLASS II Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
AngioDynamics SafeSheath Ultralite 10F recalled by Oscor
Oscor is recalling AngioDynamics SafeSheath Ultralite 10F, distributed nationwide in the US. The recall was initiated on 10 Mar 2021 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-1329-2021
- FDA event ID
- 87562
- Recalling firm
- Oscor, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2021
- FDA classified
- 1 Apr 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 Mar 2021 | Recall initiated by company | |
| 1 Apr 2021 | Classified by FDA | +22 days |
| 7 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for open seal on sterile product
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
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Where it was distributed
US Nationwide distribution in the state of New York.
Questions about this recall
Is AngioDynamics SafeSheath Ultralite 10F recalled?
Yes. Oscor recalled AngioDynamics SafeSheath Ultralite 10F on 10 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1329-2021.
Why was it recalled?
Potential for open seal on sterile product
Which lots are affected?
GUDID: 25051684026298; Lot Number DP-11759
Where was it sold?
US Nationwide distribution in the state of New York.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oscor
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|---|---|---|---|---|---|
| Device | CLASS I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS II | Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor | Oscor | Other | PA, TN |
| Device | CLASS I | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F recalled by Oscor | Oscor | Lead & Heavy Metals | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |