Zida Control Sock Black SmallRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07297539080174), received between Feb 7, 2026 and Feb 8, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Emits Odor” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2026Device Emits Odor

  09-JAN-2026 COMPLAINT # (B)(4). PATIENT AGED 37 WITH DOCUMENTED HISTORY OF URINARY URGE AND URINARY INCONTINENCE WAS PRESCRIBED ZIDA WEARABLE NEUROMODULATION DEVICE TO TREAT THESE SYMPTOMS. IMMEDIATELY UPON RECEIPT OF THE DEVICE ON JAN 9TH, 2026, THE COMPLAINANT REPORTED THAT UPON OPENING THE DEVICE PACKAGING, A STRONG FRAGRANCE WAS PRESENT ON THE SOCK. THE COMPLAINANT STATED SHE HAS A SEVERE FRAGRANCE ALLERGY AND AN AUTOIMMUNE CONDITION AFFECTING HER AIRWAY. SHE REPORTED EXPERIENCING AN ALLERGIC REACTION FOLLOWING EXPOSURE TO THE ODOR. THE DEVICE WAS NOT WORN OR USED. THE SOCK WAS ISOLATED AND PLACED IN A BAG. THE COMPLAINT WAS RECORDED AND DEEMED NOT TO REQUIRE MDR REPORTING BECAUSE THERE WAS NO INDICATION THAT THE ALLERGIC REACTION MET THE DEFINITION OF A SERIOUS INJURY. AN INVESTIGATION WAS OPENED AND FOUND THIS TO BE AN ISOLATED INCIDENT RELATED TO A PATIENT WITH UNIQUE CIRCUMSTANCES AND THE INITIAL INVESTIGATION WAS CLOSED. THE PATIENT LATER CONTACTED THE COMPANY VIA EMAIL 17-JAN-2026 AND STATED SHE HAS NOT ATTEMPTED TO LAUNDER THE SOCK AND MAY REQUIRE ASSISTANCE WITH WASHING INSTRUCTIONS. THE PATIENT INDICATED SHE DOES NOT INTEND TO BEGIN USING THE SOCK UNTIL MID TO LATE THE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24288212 ↗
• InjuryFeb 7, 2026Device Emits Odor

  ON 09-JAN-2026 COMPLAINT # (B)(4). PATIENT AGED 37 WITH DOCUMENTED HISTORY OF URINARY URGE AND URINARY INCONTINENCE WAS PRESCRIBED ZIDA WEARABLE NEUROMODULATION DEVICE TO TREAT THESE SYMPTOMS. IMMEDIATELY UPON RECEIPT OF THE DEVICE ON (B)(6) 2026, THE COMPLAINANT REPORTED THAT UPON OPENING THE DEVICE PACKAGING, A STRONG FRAGRANCE WAS PRESENT ON THE SOCK. THE COMPLAINANT STATED SHE HAS A SEVERE FRAGRANCE ALLERGY AND AN AUTOIMMUNE CONDITION AFFECTING HER AIRWAY. SHE REPORTED EXPERIENCING AN ALLERGIC REACTION FOLLOWING EXPOSURE TO THE ODOR. THE DEVICE WAS NOT WORN OR USED. THE SOCK WAS ISOLATED AND PLACED IN A BAG. THE COMPLAINT WAS RECORDED AND DEEMED NOT TO REQUIRE MDR REPORTING BECAUSE THERE WAS NO INDICATION THAT THE ALLERGIC REACTION MET THE DEFINITION OF A SERIOUS INJURY. AN INVESTIGATION WAS OPENED AND FOUND THIS TO BE AN ISOLATED INCIDENT RELATED TO A PATIENT WITH UNIQUE CIRCUMSTANCES AND THE INITIAL INVESTIGATION WAS CLOSED. THE PATIENT LATER CONTACTED THE COMPANY VIA EMAIL (B)(6) 2026 AND STATED SHE HAS NOT ATTEMPTED TO LAUNDER THE SOCK AND MAY REQUIRE ASSISTANCE WITH WASHING INSTRUCTIONS. THE PATIENT INDICATED SHE DOES NOT INTEND TO BEGIN USING THE SOCK UNTIL MID TO LATE TH

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24285805 ↗