As checked September 29, 2026, the FDA record lists an open Class II recall for specified XERF EFFECTOR 60 lots. The manufacturer told customers to stop using and return affected tips because manufacturing defects could, on rare occasions, lead to adverse events. The record does not identify the Garden City participating location or establish that it has affected stock.
What does the FDA notice actually cover?
The FDA recall record Z-0146-2026 names XERF EFFECTOR 60, with model/catalog numbers 1101210000, 1101210100, and 1101210200. It lists five serial or lot identifiers: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. The affected devices were manufactured from April 1 through August 20, 2025, according to the record.
The firm began its action September 4, 2025; FDA posted the classified recall October 14, 2025. At our September 29, 2026 check, the FDA page still showed “Open, Classified.” A recall number ending in 2026 does not mean the action began in 2026. The FDA says an open record means not all products have been corrected or removed.
What did the manufacturer ask customers to do?
The FDA summarizes an urgent field safety notification sent to consignees. It instructed them to stop using the affected devices and return them. The stated reason was a manufacturing defect that could, on rare occasions, result in adverse events. The public page does not quantify an individual patient's risk, describe outcomes at the Garden City location, or say every XERF tip is affected.
FDA lists distribution in several U.S. states and abroad. Michigan is not among the U.S. states shown in that record. Distribution lists can be incomplete as a practical inventory check, so a location should still verify its own products by model and lot rather than relying on geography.
How is this different from FDA clearance?
XERF also has a separate FDA 510(k) record, K251327, with a substantial-equivalence decision dated August 11, 2025. The listed indication is dermatologic and general surgical use for electrocoagulation and hemostasis. A clearance record and a later lot-specific recall answer different questions. Neither proves that every aesthetic claim is an FDA-cleared indication.
Our broader XERF safety guide covers study adverse-event reporting, the FDA indication, and consultation screening. This update stays focused on the exact recall notice and what to ask about inventory controls.
“Do you check each XERF EFFECTOR 60 tip's model and lot against current FDA and manufacturer notices before use? Who documents that check?” The treating location should answer from its own records. Detroit Beauty Connect cannot verify its inventory from the FDA page.
What should you do before an appointment?
- Ask the treating professional how current device and tip notices are checked.
- Ask what procedure they follow when a product matches a recall notice.
- Discuss your own medical history, expected reactions, and whom to contact after treatment.
- Recheck the live FDA record if you are reading this after September 2026; its status can change.
The American Academy of Dermatology recommends asking about risks, alternatives, and the experience of the person performing a cosmetic procedure. XERF inquiries through this site concern a participating location in Garden City, Michigan. Book a free consultation
Primary sources
These records support the factual details above. Study findings belong to the enrolled patients, and FDA records should be checked for later updates.
- FDA, XERF EFFECTOR 60 recall Z-0146-2026
- FDA, XERF 510(k) K251327
- FDA, XERF indications for use
- American Academy of Dermatology, questions before cosmetic treatment
Researched by Detroit Beauty Connect, September 29, 2026. This is informational content, not medical advice or a claim of clinician review.