Elekta Advanced Gynecological Applicator Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Elekta, Inc. is recalling 586 units of the Advanced Gynecological Applicator due to risk of the intrauterine tube tip detaching and remaining in patients.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Elekta, Inc. initiated a voluntary recall of the Advanced Gynecological Applicator after identifying safety concerns that the tip of the intrauterine tube (IU tube) may detach and remain within a patient.
Which Products Are Affected
The recall involves the Brachytherapy Applicator, brand name Advanced Gynecological Applicator, intended for intracavitary brachytherapy for cancer treatment of the cervix and endometrium. A total of 586 units are affected under lot codes: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131. Distribution includes U.S. nationwide and numerous countries worldwide.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter for return or other actions regarding affected devices.
Why This Matters
The recall addresses a potential risk of device components remaining in patients during brachytherapy procedures.
Source
FDA Recall Number Z-2711-2026 (Class II)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,112 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.