CLASS II Device recall · Reported 6 Feb 2013 · FDA Enforcement Report
Rectal Retractors, stainless steel recalled by Varian Medical Systems
Varian Medical Systems is recalling Rectal Retractors, stainless steel, distributed nationwide in the US. The recall was initiated on 12 Apr 2012 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-0759-2013
- FDA event ID
- 61879
- Recalling firm
- Varian Medical Systems, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2012
- FDA classified
- 31 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 12 Apr 2012 | Recall initiated by company | |
| 31 Jan 2013 | Classified by FDA | +294 days |
| 6 Feb 2013 | 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
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Which lots are affected?
All lots
Where was it sold?
US Nationwide Distribution
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 61879This product is part of a recall event; the main page for the event is Rectal Retractors, titanium recalled by Varian Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rectal Retractors, titanium recalled by Varian Medical Systems | Varian Medical Systems | Other | Nationwide |
More recalls from Varian Medical Systems
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Varian Multileaf Collimator [MLC] recalled by Varian Medical Systems | Varian Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Eclipse(TM) Treatment Planning System recalled by Varian Medical Systems | Varian Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | TrueBeam Radiotherapy Delivery System recalled by Varian Medical Systems | Varian Medical Systems | Other | Nationwide |
| Device | CLASS II | VitalBeam Radiotherapy Delivery System recalled | Varian Medical Systems | Other | Nationwide |
| Device | CLASS II | Eclipse Treatment Planning System recalled by Varian Medical Systems | Varian Medical Systems | Other | FL, NJ, TN |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |