Elekta, Inc. Brand Name: Brachytherapy Applicator Product Name: Advanced recall: Due to safety concerns regarding the detachment of the tip
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2711-2026
- Published
- July 15, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Elekta, Inc.
- Product type
- Medical devices
- Units affected
- 586
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131
- UPC codes
- 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131
Products covered by this recall
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Check your product
The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 08717213055001
- 08717213055018
- 08717213055025
- 08717213055049
- 08717213055056
- 08717213055063
- 08717213055087
- 08717213055094
- 08717213055100
- 08717213055117
- 08717213055131
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 08717213055001
- 08717213055018
- 08717213055025
- 08717213055049
- 0871721
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Elekta, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Elekta, Inc. — 400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Elekta, Inc. medical devices recalled?
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 08717213055001, 08717213055018, 08717213055025; lot code 08717213055001, 08717213055018, 08717213055025. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · 3 months ago
Elekta, Inc. Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name recall: Due to safety concerns regarding the detachment of the tip
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
-
Class II · 3 months ago
Elekta, Inc. Brand Name: Geneva Product Name: Brachytherapy Applicator recall: Due to safety concerns regarding the detachment of the tip
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
-
Class II · 4 months ago
Elekta, Inc. Mosaiq Oncology Information System recall: Software may fail to load adapted baseline shift plan during treatment
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
-
Class II · 6 months ago
Elekta, Inc. Brand Name: Leksell Vantage Arc System REF: 1053958 recall: Locking mechanisms may not properly secure to the Arc system
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
-
Class II · 7 months ago
Elekta, Inc. Brand Name: Leksell Gamma Knife recall: Due to adapter not being properly aligned or locked in place
Due to adapter not being properly aligned or locked in place.
-
Class II · 8 months ago
Elekta, Inc. Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment recall: Due to an error when defining a new stereotactic reference that users fail
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan…