Varian Medical Systems Recalls Titanium Rectal Retractors for Brachytherapy
Varian Medical Systems is recalling 152 titanium rectal retractors used in brachytherapy due to potential contamination risks 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 (potential infection, toxicity, or allergic reaction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Varian Medical Systems, Inc. is recalling 152 units of titanium Rectal Retractors (item # AL07368000). These devices are components of Varian Medical Ring and Tandem Applicator Sets intended for use in brachytherapy. The recall covers all lots and involves US nationwide distribution.
The recall is being issued because the medical devices may become contaminated, which can cause infections, toxicity, or allergic reactions in patients. The source text does not specify the exact nature of the contamination or report any specific illnesses or injuries.
Healthcare providers and patients should stop using the affected rectal retractors and contact Varian Medical Systems for further instructions on how to proceed.
The recalled product
- Product
- Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 152
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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