Medline Industries, Inc. DYNJRA9046Recalls & reported problems

Medline Industries, Inc. · PARACERVICAL/PUDENDAL BLK KIT · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327338619), received between Sep 13, 2026 and Sep 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Mar 1, 2024Class IIOpen, Classified
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Z-1918-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Inadequacy of Device Shape and/or Size1
Physical Resistance/Sticking1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that "The issue our provider is experiencing is that the needle will not progress all the way through the needle holder-it¿s stuck on something in the needle holder."
Patient problems: Insufficient Information
MAUDE report 50948755 ↗
MalfunctionSep 13, 2026Inadequacy of Device Shape and/or Size
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747501 ↗

Device details

UDI-DI	`10195327338619`
Brand	Medline Industries, Inc.
Model	DYNJRA9046
Company	Medline Industries, Inc.
Product code	PVV · Paracervical Anesthesia Kit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 20, 2025

Device type (GMDN): General surgical procedure kit, non-medicated, single-use

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Other Paracervical Anesthesia Kit devices

Medline Industries, Inc. DYNJRA2210
Medline Industries, Inc. · Paracervical Anesthesia Kit
1 recall0 reports

All Paracervical Anesthesia Kit devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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