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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Medical Trays and Kits Recalled for Detachable Needle Guide Ring

Agency Publication Date: May 29, 2024
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Summary

Medline Industries is recalling 13,024 Centurion and Medline medical procedure trays and kits because a ring on the Trumpet Needle Guide can detach if too much pressure is applied. These kits are used in clinical settings for paracervical and pudendal nerve blocks. If the ring detaches during a procedure, it could lead to surgical complications or the ring becoming a foreign object in the patient. Consumers and healthcare providers should check their inventory for the specific tray models and lot numbers listed in this recall.

Risk

The needle guide ring can break off when excessive pressure is used, potentially causing the ring to remain inside a patient or requiring additional medical intervention to retrieve the detached part.

What You Should Do

  1. Identify if you have affected products by checking for Centurion OB INSTRUMENT TRAY (REF MN3925) with Lot Numbers 23JBX257 or 23KMG455.
  2. Check for Medline Paracervical or Pudendal kits with the following REF numbers: DYNDH1832, DYNJRA2210, DYNJRA9046, or DYNJRA9046H.
  3. Verify your Lot Numbers against the affected list, including 23KBI682, 23KBT359, 23KBX629, 23JBX245, 23LBN930, 23JBX367, 23JBX368, 23JBX369, 23JBX370, 23LBA896, 23LBH751, 23LBL612, 23LBV325, and 23LBV326.
  4. If you possess any affected units, stop using them immediately and set them aside to prevent accidental use in medical procedures.
  5. Contact your healthcare provider or Medline Industries directly at 1-800-633-5463 for further instructions on how to return the product and obtain a replacement or refund.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Contact the manufacturer or healthcare provider.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centurion OB INSTRUMENT TRAY
Model / REF:
REF MN3925
UPC Codes:
40653160122945
10653160122944
Lot Numbers:
23JBX257
23KMG455
Product: Medline PARACERVICAL PUD TRAY
Model / REF:
REF DYNDH1832
UPC Codes:
40195327330713
10195327330712
Lot Numbers:
23KBI682
23KBT359
23KBX629
Product: Medline AHS PARACERVICAL/PUDENDAL KIT
Model / REF:
REF DYNJRA2210
UPC Codes:
40195327424047
10195327424046
Lot Numbers:
23JBX245
23LBN930
Product: Medline PARACERVICAL/PUDENDAL BLK KIT (Standard)
Model / REF:
REF DYNJRA9046
UPC Codes:
40195327338610
10195327338619
Lot Numbers:
23JBX367
23JBX368
23JBX369
23JBX370
23LBA896
23LBH751
23LBL612
23LBV325
23LBV326
Product: Medline PARACERVICAL/PUDENDAL BLK KIT (H-series)
Model / REF:
REF DYNJRA9046H
UPC Codes:
40195327338610
10195327338619
Lot Numbers:
23JBX367
23LBL612
23LBV325

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94448
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical Distributors
Manufactured In: United States
Units Affected: 2 products (30 units; 12994 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.