CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Oartrac Prostate Immobilization Endorectal Balloon Device Kit recalled
Angiodynamics is recalling Oartrac Prostate Immobilization Endorectal Balloon Device Kit, distributed nationwide in the US. The recall was initiated on 19 Nov 2019 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-0709-2020
- FDA event ID
- 84382
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2019
- FDA classified
- 19 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 19 Nov 2019 | Recall initiated by company | |
| 19 Dec 2019 | Classified by FDA | +30 days |
| 25 Dec 2019 | 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
May result in readings outside of the expected accuracy range.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
Where it was distributed
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Nationwide ArizonaGeorgiaMassachusettsNew JerseyNew YorkOhioPennsylvania
Questions about this recall
Why was it recalled?
May result in readings outside of the expected accuracy range.
Which lots are affected?
Lot Numbers: 114290, 114935 UDI 00851546007066
Where was it sold?
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
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
4 other products · FDA event 84382| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | OARtrac Plus Clinical Detector Unit recalled by Angiodynamics | Angiodynamics | Device Malfunction | Nationwide | |
| CLASS II | Micro-psd Hdr recalled by Angiodynamics | Angiodynamics | Device Malfunction | Nationwide | |
| CLASS II | Micro-psd Electron recalled by Angiodynamics | Angiodynamics | Device Malfunction | Nationwide | |
| CLASS II | Micro-psd External Beam Photon recalled by Angiodynamics | Angiodynamics | Device Malfunction | Nationwide |
More recalls from Angiodynamics
All 100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |