V. Mueller GL11Recalls & reported problems
Steris Corporation · V. Mueller GRAVES VAGINAL SPECULUM MEDIUM BLADE 4 X 1-3/8 inches 10.2 X 3.5CM · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403042744), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
- Mar 16, 2023Open, Classified
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
Z-1421-2023 · Root cause: Labeling mix-ups · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
MATERIAL# GL11 BATCH# D22XBB VERBATIM: CUSTOMER RECEIVED THE WRONG ITEM IN THE CORRECT PACKAGING. THEY RECEIVED PEDERSEN SPECULUM INSIDE A GRAVES MEDIUM (GL11). PO 24040016336. BD HAS DETERMINED THAT A PORTION OF THE PRODUCTS WERE PACKAGED AND MARKED INCORRECTLY, SPECIFICALLY: CATALOG NUMBER GL11, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL31, LOT NUMBER D22XBB - CATALOG NUMBER GL31, LOT NUMBER D22XBB MAY BE MARKED, PACKAGED, AND LABELED AS CATALOG NUMBER GL11, LOT NUMBER D22XBB. INVESTIGATION OF RETURNED COMPLAINT DEVICES LED TO AN INVESTIGATION BY THE MANUFACTURER, RESULTING IN CONFIRMATION OF A PARTIAL PRODUCT MIX FOR EACH LOT. VOLUNTARY RECALL, V. MUELLER¿ GRAVES VAGINAL SPECULUM AND PEDERSON VAGINAL SPECULA WITH BD RECALL NUMBER: BDSUR# 1423507-02/16/2023-002-C
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16427501 ↗
Other SPECULUM, VAGINAL, METAL devices
- Sklar Instruments 96-2605Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar® 96-3001Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- V. Mueller GL31Steris Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar® 96-2607Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2613Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2603Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2615Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2616Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.