Regard™ OB01054ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717112938), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 4, 2021Terminated

   The kit contains a non-sterile needle.

   Z-0411-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Delivered as Unsterile Product; Device Misassembled During Manufacturing /Shipping

  IT WAS IDENTIFIED AS AN INTERNAL FINDING THAT A BULK NON-STERILE NEEDLE WAS ADDED TO A CUSTOM PROCEDURE KIT THAT IS NOT STERILIZED PRIOR TO USE. THE NEEDLE WAS ADDED TO A KIT THAT CONTAINS COMMODITY ITEMS THAT ARE USED AFTER DELIVERY FOR INFANT CARE. THE NEEDLE IS REQUIRED TO BE STERILE FOR USE. THE KITS WERE DISTRIBUTED TO 1 DISTRIBUTION CENTER, WERE THEN RETURNED TO OUR FIRM, AND WERE NOT FURTHER SHIPPED TO USER FACILITIES OR USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848934 ↗