Varian Medical Rectal Retractors Recalled for Contamination Risk
Varian Medical Systems is recalling stainless steel rectal retractors used in brachytherapy due to potential contamination that could cause infections, toxicity, or allergic reactions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection, toxicity, allergic reactions) where specific injury or illness counts are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Varian Medical Systems, Inc. is recalling 344 pieces of stainless steel rectal retractors (item # AL07289000). These devices are components of Varian Medical Ring and Tandem Applicator Sets intended for use in brachytherapy. The recall covers all lots and the products were distributed nationwide in the United States.
The recall is being issued because the medical devices may become contaminated. This contamination can cause infections, toxicity, or allergic reactions in patients.
Healthcare providers and facilities that have received these rectal retractors should stop using them immediately. They should contact Varian Medical Systems for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Varian Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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